{"id":53790,"date":"2022-07-13T09:23:29","date_gmt":"2022-07-13T09:23:29","guid":{"rendered":"https:\/\/www.kyomedinnov.com\/clinical-cro\/"},"modified":"2023-05-16T13:32:19","modified_gmt":"2023-05-16T13:32:19","slug":"clinical-cro","status":"publish","type":"page","link":"https:\/\/www.kyomedinnov.com\/en\/clinical-cro\/","title":{"rendered":"Clinical CRO"},"content":{"rendered":"

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Strategy, Methodology and Clinical Investigations<\/h1>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.17.6″ _module_preset=”default” custom_padding_tablet=”20px||||false|false” custom_padding_phone=”20px||||false|false” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/09\/investigations-cliniques-2.svg” title_text=”investigations-cliniques-2″ align_tablet=”center” align_phone=”center” align_last_edited=”on|tablet” _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”50%” width_phone=”40%” width_last_edited=”on|tablet” max_width=”70%” module_alignment=”center” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ prev_background_color=”rgba(255,255,255,0.4)” _builder_version=”4.18.0″ _module_preset=”_initial” background_enable_image=”off” top_divider_style=”none” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|phone” _builder_version=”4.19.0″ _module_preset=”default” custom_padding=”||0px||false|false” custom_padding_tablet=”||0px||false|false” custom_padding_phone=”0px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.4″ _module_preset=”85a836e9-8847-4308-9e3f-ce20dc0f2448″ hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

KYomed INNOV is a clinical CRO (Clinical Research Organization) specialized in digital health.<\/strong><\/p>\n

We support you in the realization of your clinical objectives, through all phases of your clinical roadmap. We intervene from the construction of your clinical development strategy, to the elaboration of a methodology and design for your clinical study until the realization of your clinical study in pre or post-marketing.<\/strong><\/p>\n

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Our team of specialists will be able to help you whatever your objectives are for your solution:<\/p>\n

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Our team of specialists will be able to help you whatever your objectives are for your solution:<\/p>\n

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Our team of specialists will be able to help you whatever your objectives are for your solution:<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_6,1_6,1_6,1_6,1_6,1_6″ use_custom_gutter=”on” gutter_width=”1″ make_equal=”on” module_id=”grid-info” _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”][et_pb_column type=”1_6″ _builder_version=”4.19.0″ _module_preset=”default” custom_padding=”||30px||false|false” global_colors_info=”{}”][et_pb_blurb use_icon=”on” font_icon=”||fa||900″ image_icon_width=”40px” _builder_version=”4.19.0″ _module_preset=”default” body_line_height=”1.3em” background_color=”#EEEEEE” image_icon_custom_margin=”5px||-20px||false|false” text_orientation=”center” width=”60%” width_tablet=”50%” width_phone=”100%” width_last_edited=”on|tablet” module_alignment=”center” custom_padding=”15px|10px|15px|10px|true|true” custom_padding_tablet=”20px|20px|20px|20px|true|true” custom_padding_phone=”20px|20px|20px|20px|true|true” custom_padding_last_edited=”on|tablet” module_alignment_tablet=”center” module_alignment_phone=”center” module_alignment_last_edited=”on|desktop” border_radii=”off|20px|20px|20px|20px” box_shadow_style=”preset3″ global_colors_info=”{}” body_letter_spacing__hover_enabled=”off|desktop”]<\/p>\n

Collect<\/strong> initial clinical<\/strong> data<\/strong><\/p>\n

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Demonstrate<\/strong> your claims<\/strong> scientifically<\/p>\n

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Demonstrate performance and safety<\/strong> for CE marking<\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.19.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb use_icon=”on” font_icon=”||fa||900″ image_icon_width=”40px” _builder_version=”4.18.0″ _module_preset=”default” body_line_height=”1.3em” background_color=”#EEEEEE” image_icon_custom_margin=”5px||-20px||false|false” text_orientation=”center” width=”60%” width_tablet=”50%” width_phone=”100%” width_last_edited=”on|tablet” module_alignment=”center” custom_padding=”15px|10px|15px|10px|true|true” custom_padding_tablet=”20px|20px|20px|20px|true|true” custom_padding_phone=”20px|20px|20px|20px|true|true” custom_padding_last_edited=”on|tablet” module_alignment_tablet=”center” module_alignment_phone=”center” module_alignment_last_edited=”on|desktop” custom_css_blurb_image=”vertical-align: middle;” border_radii=”off|20px|20px|20px|20px” box_shadow_style=”preset3″ global_colors_info=”{}”]<\/p>\n

Demonstrate the medico-economic<\/strong> impact for possible reimbursement<\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.19.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb use_icon=”on” font_icon=”||fa||900″ image_icon_width=”40px” _builder_version=”4.19.1″ _module_preset=”default” body_line_height=”1.3em” background_color=”#EEEEEE” image_icon_custom_margin=”5px||-20px||false|false” text_orientation=”center” width=”60%” width_tablet=”50%” width_phone=”100%” width_last_edited=”on|tablet” module_alignment=”center” custom_padding=”15px|10px|15px|10px|true|true” custom_padding_tablet=”20px|20px|20px|20px|true|true” custom_padding_phone=”20px|20px|20px|20px|true|true” custom_padding_last_edited=”on|tablet” module_alignment_tablet=”center” module_alignment_phone=”center” module_alignment_last_edited=”on|desktop” custom_css_blurb_image=”vertical-align: middle;” border_radii=”off|20px|20px|20px|20px” box_shadow_style=”preset3″ global_colors_info=”{}”]<\/p>\n

Monitor real-life use<\/strong> once your product is on the market<\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.19.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb use_icon=”on” font_icon=”||fa||900″ image_icon_width=”40px” _builder_version=”4.18.0″ _module_preset=”default” body_line_height=”1.3em” background_color=”#EEEEEE” image_icon_custom_margin=”5px||-20px||false|false” text_orientation=”center” width=”60%” width_tablet=”50%” width_phone=”100%” width_last_edited=”on|tablet” module_alignment=”center” custom_padding=”15px|10px|15px|10px|true|true” custom_padding_tablet=”20px|20px|20px|20px|true|true” custom_padding_phone=”20px|20px|20px|20px|true|true” custom_padding_last_edited=”on|tablet” module_alignment_tablet=”center” module_alignment_phone=”center” module_alignment_last_edited=”on|desktop” custom_css_blurb_image=”vertical-align: middle;” border_radii=”off|20px|20px|20px|20px” box_shadow_style=”preset3″ global_colors_info=”{}”]<\/p>\n

Demonstrate the impact<\/strong> even if you do not want to be a Medical Device<\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ admin_label=”Row” module_class=”inverse” _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” background_enable_image=”off” global_colors_info=”{}”]<\/p>\n

To optimize the duration and costs<\/strong> of your clinical phases, our clinical team supports you at each step of your roadmap<\/strong> to anticipate your needs and reinforce the quality of your results<\/strong> while meeting regulatory requirements<\/strong>.<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”4.18.0″ _module_preset=”a1d074ca-e2d0-4ab2-b4b2-9e769390c7d8″ custom_padding=”20px|25px|20px|25px|true|true” border_color_all=”#7FD072″ global_colors_info=”{}”]<\/p>\n

We are specialized in digital medical devices<\/strong> and more globally in health technologies<\/strong>.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.17.6″ _module_preset=”default” custom_padding_tablet=”||50px||false|false” custom_padding_phone=”||50px||false|false” custom_padding_last_edited=”on|phone” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/interior-of-empty-science-laboratory-with-modern-equipment-prepared-for-treatment-innovation-of-nervous-system-using-high-tech-and-microbiology-tools-for-scientific-research-in-neurological-lab-Grand-1024×576.jpg” title_text=”Interior of empty science laboratory for neurological treatment” _builder_version=”4.19.4″ _module_preset=”a1ca4c43-39cf-4674-8db0-cf5c7d50981f” width_tablet=”” width_phone=”” width_last_edited=”on|tablet” hover_enabled=”0″ global_colors_info=”{}” alt=”clinical CRO kyomedinnov” sticky_enabled=”0″][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row custom_padding_last_edited=”on|tablet” _builder_version=”4.18.0″ _module_preset=”default” custom_padding_tablet=”0px||0px||true|false” custom_padding_phone=”0px||0px||true|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider show_divider=”off” _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipi_text_highlighter text_highlighter_text=”Une offre tout-en-un adapt\u00e9e et personnalis\u00e9e” highlight_shape=”strikethrough” text_wrapper_tag=”h4″ highlight_animation_repeat_mode=”definite” _builder_version=”4.18.0″ _module_preset=”f0508cbb-f909-49fb-96e4-4ab87c30e9cf” global_colors_info=”{}”][\/dipi_text_highlighter][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Different expertise is needed to conduct a clinical study in its entirety.<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”4.19.1″ _module_preset=”a1d074ca-e2d0-4ab2-b4b2-9e769390c7d8″ global_colors_info=”{}”]<\/p>\n

This is why KYomed INNOV has built a network of qualified and complementary partners and subcontractors<\/strong> in order to accompany you in a global<\/strong> way in your clinical development, by integrating all aspects.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.17.4″ _module_preset=”default” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/medicine-doctor-and-stethoscope-touching-icon-heart-Grand-1024×567.jpg” title_text=”Medicine doctor and stethoscope touching icon heart and diagnost” _builder_version=”4.17.6″ _module_preset=”7b8db442-b654-4253-a145-2bb889cd02ce” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” module_class=”inverse” _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”85a836e9-8847-4308-9e3f-ce20dc0f2448″ global_colors_info=”{}”]<\/p>\n

The benefits?<\/strong><\/p>\n

[\/et_pb_text][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

A single contact for your study: your dedicated clinical project manager<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.19.1″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”350ms” global_colors_info=”{}”]<\/p>\n

An assurance on the quality of the work<\/strong> provided by the partners\/subcontractors of your clinical study.<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”400ms” global_colors_info=”{}”]<\/p>\n

Time saving<\/strong> in your search for stakeholders and in contracting.<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”450ms” global_colors_info=”{}”]<\/p>\n

Expert supervision<\/strong> of stakeholders<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”500ms” global_colors_info=”{}”]<\/p>\n

Stakeholders for your study who know<\/strong> each other and are used<\/strong> to working and exchanging with each other<\/strong>.<\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Section” _builder_version=”4.18.0″ _module_preset=”34a86d6c-a6ae-4c46-8166-be640ef83b27″ background_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/09\/CRO-clinique-gris-2.svg” background_image_width=”20%” background_position=”center_right” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.1″ _module_preset=”default” custom_padding=”||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipi_text_highlighter text_highlighter_text=”D\u00e9veloppement de votre dispositif m\u00e9dical” highlight_shape=”strikethrough” text_wrapper_tag=”h4″ highlight_animation_repeat_mode=”definite” _builder_version=”4.18.0″ _module_preset=”f0508cbb-f909-49fb-96e4-4ab87c30e9cf” all_text_text_align=”center” global_colors_info=”{}”][\/dipi_text_highlighter][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_5,1_5,1_5,1_5,1_5″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” _builder_version=”4.19.1″ _module_preset=”default” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”1_5″ _builder_version=”4.19.1″ _module_preset=”default” background_enable_color=”off” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|desktop” custom_css_main_element=”width: 32% !important;” border_radii=”on|30px|30px|30px|30px” global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet” custom_css_main_element_phone=”width: 100% !important;” custom_css_main_element_tablet=”width: 100% !important;”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icone_rond-1.png” title_text=”icone_rond 1″ url=”#methodo” _builder_version=”4.19.1″ _module_preset=”default” positioning=”relative” vertical_offset=”65px” horizontal_offset=”25px” z_index=”1″ vertical_offset_tablet=”75px” vertical_offset_phone=”70px” vertical_offset_last_edited=”on|phone” width=”35%” width_tablet=”20%” width_phone=”30%” width_last_edited=”on|tablet” custom_margin=”||||false|false” custom_margin_tablet=”-5%||||false|false” custom_margin_phone=”-15%||||false|false” custom_margin_last_edited=”on|tablet” animation_style=”slide” animation_delay=”200ms” animation_speed_curve=”ease-out” global_colors_info=”{}”][\/et_pb_image][et_pb_blurb title=”Methodology and Clinical Design” _builder_version=”4.19.1″ _module_preset=”default” header_font=”|600|||||||” header_font_size=”25px” background_color=”#FFFFFF” text_orientation=”center” custom_padding=”40px|20px|30px|20px|false|true” animation_style=”slide” animation_direction=”top” animation_delay=”1400ms” animation_intensity_slide=”10%” animation_speed_curve=”ease-out” link_option_url=”#methodo” header_font_size_tablet=”22px” header_font_size_phone=”22px” header_font_size_last_edited=”on|desktop” border_radii=”on|30px|30px|30px|30px” box_shadow_style=”preset3″ global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet”]<\/p>\n

According to your objectives and your strategy in order to optimize the costs and duration of your clinical phases.<\/em><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.19.1″ _module_preset=”default” custom_padding_last_edited=”off|tablet” custom_css_main_element=”width: 1% !important;” global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet” custom_css_main_element_tablet=”width: 100% !important;||margin: 0;” custom_css_main_element_phone=”width: 100% !important;||margin: 0;”][et_pb_icon font_icon=”5||divi||400″ icon_color=”#293540″ font_icon_tablet=”3||divi||400″ font_icon_phone=”3||divi||400″ font_icon_last_edited=”on|tablet” align_tablet=”” align_phone=”” align_last_edited=”on|tablet” disabled_on=”on|on|off” _builder_version=”4.19.1″ _module_preset=”default” transform_scale_last_edited=”off|tablet” transform_translate_last_edited=”off|tablet” transform_rotate_last_edited=”off|tablet” transform_skew_last_edited=”off|tablet” transform_origin_last_edited=”off|tablet” transform_styles_last_edited=”off|tablet” positioning=”relative” vertical_offset=”195px” horizontal_offset=”-45px” vertical_offset_tablet=”195px” vertical_offset_phone=”195px” vertical_offset_last_edited=”on|desktop” custom_margin_tablet=”-40%|||5%|false|false” custom_margin_phone=”-70%|||20%|false|false” custom_margin_last_edited=”on|tablet” animation_style=”slide” animation_direction=”left” animation_duration=”750ms” animation_delay=”600ms” animation_speed_curve=”ease-out” animation_direction_tablet=”top” animation_direction_phone=”top” animation_direction_last_edited=”on|tablet” global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet” custom_css_main_element_tablet=”display: none;” custom_css_main_element_phone=”display: none;”][\/et_pb_icon][et_pb_icon font_icon=”3||divi||400″ icon_color=”#293540″ disabled_on=”off|off|on” _builder_version=”4.19.1″ _module_preset=”default” positioning=”absolute” vertical_offset=”-20px” horizontal_offset=”237px” vertical_offset_tablet=”0px” vertical_offset_phone=”0px” vertical_offset_last_edited=”on|phone” horizontal_offset_tablet=”0px” horizontal_offset_phone=”110px” horizontal_offset_last_edited=”on|phone” position_origin_a_tablet=”” position_origin_a_phone=”center_center” position_origin_a_last_edited=”on|tablet” position_origin_f_tablet=”” position_origin_f_phone=”” position_origin_f_last_edited=”on|tablet” position_origin_r_tablet=”” position_origin_r_phone=”” position_origin_r_last_edited=”on|tablet” custom_margin=”||||false|false” custom_margin_tablet=”-4%||-20%||false|false” custom_margin_phone=”5%||||false|false” custom_margin_last_edited=”on|tablet” animation_style=”fade” animation_delay=”600ms” positioning_tablet=”absolute” positioning_phone=”absolute” positioning_last_edited=”on|tablet” global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet” custom_css_main_element_tablet=”width: 100% !important;||margin: 0;” custom_css_main_element_phone=”width: auto;”][\/et_pb_icon][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.19.1″ _module_preset=”default” background_enable_color=”off” custom_css_main_element=”width: 32% !important;” border_radii=”on|30px|30px|30px|30px” global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet” custom_css_main_element_tablet=”width: 100% !important;||margin-top: -15%;” custom_css_main_element_phone=”width: 100% !important;||margin-top: -25% !important;”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icone_rond-2.png” title_text=”icone_rond 2″ url=”#investigation” _builder_version=”4.18.0″ _module_preset=”default” positioning=”relative” vertical_offset=”65px” horizontal_offset=”25px” z_index=”1″ vertical_offset_tablet=”75px” vertical_offset_phone=”70px” vertical_offset_last_edited=”on|phone” width=”35%” width_tablet=”20%” width_phone=”30%” width_last_edited=”on|tablet” animation_style=”slide” animation_delay=”800ms” animation_speed_curve=”ease-out” global_colors_info=”{}”][\/et_pb_image][et_pb_blurb title=”Clinical Investigation” _builder_version=”4.18.0″ _module_preset=”default” header_font=”|600|||||||” header_font_size=”25px” background_color=”#FFFFFF” text_orientation=”center” custom_padding=”40px|20px|30px|20px|false|true” animation_style=”slide” animation_direction=”top” animation_delay=”1400ms” animation_intensity_slide=”10%” animation_speed_curve=”ease-out” link_option_url=”#investigation” header_font_size_tablet=”22px” header_font_size_phone=”22px” header_font_size_last_edited=”on|desktop” border_radii=”on|30px|30px|30px|30px” box_shadow_style=”preset3″ global_colors_info=”{}”]<\/p>\n

Demonstrate the performance and safety of your medical device.<\/em><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.19.1″ _module_preset=”default” custom_css_main_element=”width: 1% !important;” global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet” custom_css_main_element_tablet=”width: 100% !important;||margin: 0;” custom_css_main_element_phone=”width: 100% !important;||margin: 0;”][et_pb_icon font_icon=”5||divi||400″ icon_color=”#293540″ font_icon_tablet=”3||divi||400″ font_icon_phone=”3||divi||400″ font_icon_last_edited=”on|tablet” disabled_on=”on|on|off” _builder_version=”4.17.6″ _module_preset=”default” positioning=”relative” vertical_offset=”195px” horizontal_offset=”-45px” vertical_offset_tablet=”195px” vertical_offset_phone=”195px” vertical_offset_last_edited=”on|desktop” custom_margin_tablet=”-40%|||5%|false|false” custom_margin_phone=”-70%|||20%|false|false” custom_margin_last_edited=”on|tablet” animation_style=”slide” animation_direction=”left” animation_duration=”750ms” animation_delay=”1200ms” animation_speed_curve=”ease-out” animation_direction_tablet=”top” animation_direction_phone=”top” animation_direction_last_edited=”on|tablet” locked=”off” global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet” custom_css_main_element_tablet=”display: none;” custom_css_main_element_phone=”display: none;”][\/et_pb_icon][et_pb_icon font_icon=”3||divi||400″ icon_color=”#293540″ disabled_on=”off|off|on” _builder_version=”4.19.1″ _module_preset=”default” positioning=”absolute” position_origin_a=”top_center” vertical_offset=”-20px” horizontal_offset=”237px” vertical_offset_tablet=”0px” vertical_offset_phone=”0px” vertical_offset_last_edited=”on|phone” horizontal_offset_tablet=”0px” horizontal_offset_phone=”110px” horizontal_offset_last_edited=”on|phone” position_origin_a_tablet=”top_center” position_origin_a_phone=”center_center” position_origin_a_last_edited=”on|tablet” position_origin_f_tablet=”” position_origin_f_phone=”” position_origin_f_last_edited=”on|tablet” position_origin_r_tablet=”” position_origin_r_phone=”” position_origin_r_last_edited=”on|tablet” custom_margin=”||||false|false” custom_margin_tablet=”-4%||-20%||false|false” custom_margin_phone=”5%||||false|false” custom_margin_last_edited=”on|tablet” animation_style=”fade” animation_delay=”600ms” positioning_tablet=”absolute” positioning_phone=”absolute” positioning_last_edited=”on|phone” global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet” custom_css_main_element_tablet=”width: 100% !important;||margin: 0;” custom_css_main_element_phone=”width: auto;”][\/et_pb_icon][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.19.1″ _module_preset=”default” background_enable_color=”off” custom_css_main_element=”width: 32% !important;” border_radii=”on|30px|30px|30px|30px” global_colors_info=”{}” custom_css_main_element_last_edited=”on|phone” custom_css_main_element_tablet=”width: 95% !important;||margin-top: -15%;” custom_css_main_element_phone=”width: 100% !important;||margin-top: -25% !important;”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icone_rond-3.png” title_text=”icone_rond 3″ url=”#scac” _builder_version=”4.17.6″ _module_preset=”default” positioning=”relative” vertical_offset=”65px” horizontal_offset=”25px” z_index=”1″ vertical_offset_tablet=”75px” vertical_offset_phone=”70px” vertical_offset_last_edited=”on|phone” width=”35%” width_tablet=”20%” width_phone=”30%” width_last_edited=”on|tablet” animation_style=”slide” animation_delay=”1200ms” animation_speed_curve=”ease-out” global_colors_info=”{}”][\/et_pb_image][et_pb_blurb title=”Post-market clinical follow-up” _builder_version=”4.19.1″ _module_preset=”default” header_font=”|600|||||||” header_font_size=”25px” background_color=”#FFFFFF” text_orientation=”center” custom_padding=”40px|20px|30px|20px|false|true” animation_style=”slide” animation_direction=”top” animation_delay=”1400ms” animation_intensity_slide=”10%” animation_speed_curve=”ease-out” link_option_url=”#scac” header_font_size_tablet=”22px” header_font_size_phone=”22px” header_font_size_last_edited=”on|desktop” border_radii=”on|30px|30px|30px|30px” box_shadow_style=”preset3″ global_colors_info=”{}” custom_css_main_element_last_edited=”on|tablet”]<\/p>\n

For a medical device that is always efficient, safe and compliant with current standards.<\/em><\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/\/www.kyomedinnov.com\/en\/our-projects\/#cro-clinique” button_text=”The solutions we support” _builder_version=”4.18.0″ _module_preset=”a791ea40-b723-47fd-9c77-c58bf4d3d46c” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_id=”methodo” _builder_version=”4.18.0″ _module_preset=”_initial” background_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/09\/CRO-clinique-gris-2.svg” background_size=”custom” background_image_width=”20%” background_position=”bottom_right” background_horizontal_offset=”-3%” background_vertical_offset=”28%” background_last_edited=”on|phone” background_enable_image_phone=”off” background_horizontal_offset_tablet=”-5%” background_vertical_offset_tablet=”68%” background_vertical_offset_phone=”0%” global_colors_info=”{}”][et_pb_row custom_padding_last_edited=”on|phone” _builder_version=”4.19.0″ _module_preset=”default” custom_padding=”0px||||false|false” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”0px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider color=”#00B9F2″ divider_position=”center” divider_weight=”4px” _builder_version=”4.17.4″ _module_preset=”720f3159-8b53-4df2-973a-775c8dce21fa” width=”10%” width_tablet=”20%” width_phone=”20%” width_last_edited=”on|tablet” border_radii=”on|1px|1px|1px|1px” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.17.6″ _module_preset=”0294cc11-a8bb-4cff-a429-6bb8a3a07242″ global_colors_info=”{}”]<\/p>\n

Strategy, Methodology and Clinical Investigations<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.19.0″ _module_preset=”0c90df4f-8445-4953-8b21-6914f398f2de” global_colors_info=”{}”]<\/p>\n

We support you in the design of your clinical study according to your objectives and your strategy to optimize the costs and duration of your clinical phases.<\/h3>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.17.6″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” custom_padding_tablet=”||30px||false|false” custom_padding_phone=”||30px||false|false” custom_padding_last_edited=”on|tablet” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

With more than 8 years of experience<\/strong> in real-life clinical trials<\/strong> and with an experienced team, the methodologies and clinical designs co-constructed manage to blend your strategic objectives<\/strong>, the scientific<\/strong> knowledge on the pathology concerned, the use of real-life data<\/strong> (RWD, RWE, PROMS, PREMS) and the regulation<\/strong> of clinical trials.<\/p>\n

It is this balance that is recognized and allows us to build a solid foundation to make your project a success.<\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.17.4″ _module_preset=”default” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/close-up-of-woman-hands-using-glucose-meter-on-finger-to-check-blood-sugar-level-1-Grand-1024×683.jpg” title_text=”Close up of woman hands using Glucose meter on finger to check b” _builder_version=”4.17.6″ _module_preset=”a1ca4c43-39cf-4674-8db0-cf5c7d50981f” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_image_width=”40%” background_position=”bottom_right” background_horizontal_offset=”3%” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipi_text_highlighter text_highlighter_text=”Strat\u00e9gie clinique” highlight_shape=”strikethrough” text_wrapper_tag=”h3″ highlight_animation_repeat_mode=”definite” module_class=”court” _builder_version=”4.19.0″ _module_preset=”f0508cbb-f909-49fb-96e4-4ab87c30e9cf” global_colors_info=”{}”][\/dipi_text_highlighter][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}” content_image_icon_width_phone=”50px” content_image_icon_width_last_edited=”on|phone” content_title_font_size_phone=”23px” content_title_font_size_last_edited=”on|phone” content_image_icon_width_tablet=”70px” content_title_font_size_tablet=”25px”]<\/p>\n

We will first discuss your clinical development strategy<\/strong> with you to identify the clinical roadmap of your project<\/strong>. If you have already worked on your clinical strategy, we will build on your work and optimize<\/strong> it if necessary. Otherwise, we will start from a blank page and build it together<\/strong>.<\/p>\n

For this we will analyze all the information related to your device:<\/strong><\/p>\n

[\/et_pb_text][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” global_colors_info=”{}”]<\/p>\n

Its step of development<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.19.1″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Your market access strategy<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.19.1″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Your business model<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

The applicable regulations<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Targeted markets<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

The care pathway(s)<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Literature<\/strong> on the subject (incidence, epidemiology, eligible population and recruitment)<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” content_max_width_tablet=”90%” content_max_width_phone=”90%” content_max_width_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Possible competing or complementary solutions<\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”a1d074ca-e2d0-4ab2-b4b2-9e769390c7d8″ global_colors_info=”{}”]<\/p>\n

To deal with each of these aspects, we will build a team<\/strong> around your project that will be composed of our experts<\/strong> but also of experts from our network<\/strong>.<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We will propose personalized<\/strong> services according to different criteria (size of your company, deadlines, budgets…) but also to the type of expertise<\/strong> you need<\/strong> (market access, regulatory, vigilance…).<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.17.6″ _module_preset=”default” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/medicine-doctor-wearing-virtual-reality-glasses-check-and-testing-result-of-patient-with-simulator-Grand-1024×499.jpg” title_text=”Medicine doctor wearing virtual reality glasses checking and te” _builder_version=”4.17.6″ _module_preset=”7b8db442-b654-4253-a145-2bb889cd02ce” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”on|on|off” _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”#contact” button_text=”I need help to define my clinical strategy” _builder_version=”4.18.0″ _module_preset=”a791ea40-b723-47fd-9c77-c58bf4d3d46c” global_colors_info=”{}” button_bg_enable_color__hover=”on”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row module_id=”methodo” _builder_version=”4.17.4″ _module_preset=”default” custom_margin=”30px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipi_text_highlighter text_highlighter_text=”M\u00e9thodologie et design clinique” highlight_shape=”strikethrough” text_wrapper_tag=”h3″ highlight_animation_repeat_mode=”definite” _builder_version=”4.17.6″ _module_preset=”f0508cbb-f909-49fb-96e4-4ab87c30e9cf” global_colors_info=”{}”][\/dipi_text_highlighter][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Our clinical project managers, methodologists and statisticians will then meet with your team (sponsor and specialized healthcare professional) to define together the primary<\/strong> and secondary objectives<\/strong> to build the design of your clinical study<\/strong> in line with your requirements<\/strong>.
We will base our work on the data in the literature or on any existing clinical data on your device.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row module_class=”inverse” _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” custom_padding_tablet=”||||false|false” custom_padding_phone=”||||false|false” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_text _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We will assist you in determining<\/strong> :<\/p>\n

[\/et_pb_text][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.19.1″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

The type of study<\/strong> adapted methodologically<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

The primary<\/strong> and secondary objectives<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

The evaluation criteria<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

The number of subjects required<\/strong> (NSN)<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

The duration<\/strong> of the study<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Investigator site(s)<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Study population<\/strong> (inclusion and non-inclusion criteria)<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Anticipated study schedule<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” icon_placement=”left” content_max_width=”90%” _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”||10px||false|false” animation_style=”fade” animation_delay=”300ms” global_colors_info=”{}”]<\/p>\n

Recruitment<\/strong> process<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” global_colors_info=”{}”]<\/p>\n

Regulatory submissions<\/strong> required for the study<\/p>\n

[\/et_pb_blurb][et_pb_blurb title=”Deliverable :” image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icone_livrables-2.png” _builder_version=”4.18.0″ _module_preset=”99d736ba-ec92-4cf8-878c-35f6a34a30ab” global_colors_info=”{}”]<\/p>\n

At the end of this step, we will provide you with a draft synopsis<\/strong> that will allow you to establish and concretize the methodology and design of your study<\/strong>.<\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.18.0″ _module_preset=”default” background_enable_color=”off” width=”50%” width_tablet=”80%” width_phone=”80%” width_last_edited=”on|tablet” custom_padding=”0px||||false|false” animation_style=”fade” animation_delay=”100ms” animation_speed_curve=”ease-out” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.18.0″ _module_preset=”default” background_color=”#EEEEEE” custom_padding=”20px|20px|20px|20px|true|true” border_radii=”on|20px|20px|20px|20px” global_colors_info=”{}”][et_pb_blurb title=”Next step?” use_icon=”on” font_icon=”||fa||900″ icon_color=”#293540″ icon_placement=”left” image_icon_width=”31px” content_max_width=”100%” icon_placement_tablet=”left” icon_placement_phone=”top” icon_placement_last_edited=”on|phone” _builder_version=”4.18.0″ _module_preset=”default” header_font=”|700|||||||” background_enable_color=”off” custom_margin=”||10px||false|false” header_font_size_tablet=”” header_font_size_phone=”22px” header_font_size_last_edited=”on|phone” custom_css_blurb_image=”transform: rotate(90deg)” global_colors_info=”{}”][\/et_pb_blurb][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

The construction and writing of all the clinical documentation<\/strong> for your study to make your regulatory submissions<\/strong> and obtain the authorizations<\/strong> to launch this study.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|off” _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”#contact” button_text=”I need help defining my methodology and clinical design” _builder_version=”4.17.4″ _module_preset=”a791ea40-b723-47fd-9c77-c58bf4d3d46c” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

For each project we support, KYomed INNOV applies its quality approach<\/strong> so that your clinical investigation is designed and carried out in accordance with the regulations<\/strong> in force.<\/p>\n

We can also involve a regulatory expert<\/strong> to refine the positioning<\/strong> of your solution to avoid being a medical device or to see how to optimize its classification.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.17.6″ _module_preset=”default” custom_padding_tablet=”30px||30px||true|false” custom_padding_phone=”30px||||false|false” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/brain-study-background-for-mental-health-care-medical-technology-Grand.jpg-1024×683.webp” title_text=”brain-study-background-for-mental-health-care-medical-technology-Grand.jpg” _builder_version=”4.17.6″ _module_preset=”a1ca4c43-39cf-4674-8db0-cf5c7d50981f” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_id=”investigation” _builder_version=”4.18.0″ _module_preset=”34a86d6c-a6ae-4c46-8166-be640ef83b27″ background_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/09\/CRO-clinique-gris-2.svg” background_image_width=”20%” background_horizontal_offset=”-3%” background_vertical_offset=”40%” background_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider color=”#00B9F2″ divider_position=”center” divider_weight=”4px” _builder_version=”4.17.4″ _module_preset=”default” width=”10%” width_tablet=”20%” width_phone=”20%” width_last_edited=”on|tablet” border_radii=”on|1px|1px|1px|1px” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.17.6″ _module_preset=”0294cc11-a8bb-4cff-a429-6bb8a3a07242″ global_colors_info=”{}”]<\/p>\n

Clinical investigation<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.19.1″ _module_preset=”0c90df4f-8445-4953-8b21-6914f398f2de” global_colors_info=”{}”]<\/p>\n

We help you to lead and oversee your real-life study in order to demonstrate the performance and safety of your medical device and evaluate its medical or medico-economic impact.<\/h3>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_3,1_3″ make_equal=”on” custom_padding_last_edited=”on|phone” _builder_version=”4.19.0″ _module_preset=”default” custom_padding_tablet=”” custom_padding_phone=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”2_3″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.1″ _module_preset=”default” text_font_size=”19px” global_colors_info=”{}”]<\/p>\n

What is the difference between a clinical investigation, a clinical study, a clinical trial, and clinical evaluation?<\/strong><\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Clinical investigation<\/strong>, clinical study<\/strong> and clinical trial<\/strong> are synonymous terms. They refer to a systematic investigation involving one or more human subjects, undertaken to verify the safety<\/strong> or performance<\/strong> of a medical device<\/strong>.<\/p>\n

However, clinical evaluation<\/strong> is a more comprehensive term. It contains other aspects in addition to the clinical investigation part, such as the bibliography, the technical file and the existing safety and clinical data.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.17.4″ _module_preset=”default” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/doctor-holding-by-hands-scan-after-ultrasound-diagnostic-Grand-1024×683.jpg” title_text=”Doctor holding by hands scan after ultrasound diagnostic.” _builder_version=”4.17.6″ _module_preset=”7b8db442-b654-4253-a145-2bb889cd02ce” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.6″ _module_preset=”default” width_tablet=”80%” width_phone=”80%” width_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.1″ _module_preset=”d4b4e832-696b-4521-820b-303d99dd66ae” global_colors_info=”{}”]<\/p>\n

Whether you want to collect initial clinical data on your solution, demonstrate the clinical performance, efficacy or safety of your medical device with a view to CE marking, demonstrate its medical or medico-economic impact, or collect real-life data, our clinical team will support you in the implementation<\/strong>, management<\/strong> and supervision<\/strong> of your clinical investigation.<\/strong>.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row custom_padding_last_edited=”on|phone” _builder_version=”4.18.0″ _module_preset=”default” custom_padding_tablet=”” custom_padding_phone=”||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipi_text_highlighter text_highlighter_text=”Les \u00e9tapes d’une investigation clinique” highlight_shape=”strikethrough” text_wrapper_tag=”h3″ highlight_animation_repeat_mode=”definite” _builder_version=”4.17.6″ _module_preset=”f0508cbb-f909-49fb-96e4-4ab87c30e9cf” global_colors_info=”{}”][\/dipi_text_highlighter][et_pb_text _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

After working on the methodology and the design of your study, we propose you a personalized accompaniment, according to your needs, for the realization of your study.<\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” custom_margin=”30px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Clinical investigation” image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/09\/investigations-cliniques-2.svg” icon_placement=”left” image_icon_width=”115px” content_max_width=”75%” icon_placement_tablet=”left” icon_placement_phone=”top” icon_placement_last_edited=”on|phone” image_icon_width_tablet=”115px” image_icon_width_phone=”150px” image_icon_width_last_edited=”on|phone” content_max_width_tablet=”100%” content_max_width_phone=”100%” content_max_width_last_edited=”on|tablet” module_id=”cro-icon” _builder_version=”4.19.1″ _module_preset=”default” header_font=”|700|||||||” text_orientation_tablet=”” text_orientation_phone=”center” text_orientation_last_edited=”on|phone” global_colors_info=”{}” custom_css_blurb_image_last_edited=”on|phone” custom_css_blurb_image_phone=”margin: auto;||margin-bottom: 20px;”]<\/p>\n

A clinical investigation is a process that takes place in 10 steps<\/strong>, which we can accompany<\/strong> you through, depending on your resources and your internal skills.<\/p>\n

[\/et_pb_blurb][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/Ligne-fleche.png” title_text=”Ligne fl\u00e8che” _builder_version=”4.17.4″ _module_preset=”default” animation_style=”slide” animation_direction=”top” animation_duration=”750ms” animation_delay=”400ms” animation_speed_curve=”ease-out” global_colors_info=”{}”][\/et_pb_image][dipi_advanced_tabs use_sticky_tabs=”off” use_tabs_fullwidth=”off” tabs_min_width=”30%” tabs_max_width=”100%” use_tabs_fullwidth_tablet=”off” tabs_min_width_tablet=”30%” tabs_max_width_tablet=”100%” tabs_placement=”row” tabs_container_width=”30%” tabs_placement_tablet=”row” tabs_placement_phone=”row” tabs_container_padding=”10px|0px|10px|0px|false|false” tabs_container_margin=”10px|0px|10px|0px|false|false” use_scroll_to_content=”on” content_padding=”20px|40px|20px|40px|true|true” content_margin=”10px|10px|10px|30px|false|false” tabs_text_padding=”15px|5px|5px|5px|false|false” tabs_icon_margin=”0px||0px|0px|false|false” tabs_text_padding_active=”15px|5px|5px|5px|false|false” tabs_icon_margin_active=”0px||0px|0px|false|false” use_active_arrow=”off” content_bg_color=”RGBA(255,255,255,0)” tabs_bg_color=”RGBA(255,255,255,0)” tabs_item_bg_color=”RGBA(255,255,255,0)” tabs_item_active_bg_color=”#F9F7FF” content_padding_tablet=”20px|20px|20px|20px|true|true” content_padding_phone=”20px|20px|20px|20px|true|true” content_padding_last_edited=”on|tablet” disabled_on=”on|off|off” module_class=”tablarge” _builder_version=”4.19.1″ _module_preset=”default” title_active_font=”|600|||||||” title_active_text_color=”#293540″ background_enable_image=”off” border_color_all_content_wrapper=”RGBA(255,255,255,0)” border_color_all_tabs_wrapper=”RGBA(255,255,255,0)” border_width_right_tabs_wrapper=”2px” border_color_right_tabs_wrapper=”#EEEEEE” border_color_all_tabs_item_active=”#7FD072″ border_width_right_tabs_item_active=”2px” border_color_right_tabs_item_active=”#7FD072″ border_color_left_tabs_item_active=”#7FD072″ border_width_right_tabs_item_active_tablet=”2px” border_width_right_tabs_item_active_phone=”0px” border_width_right_tabs_item_active_last_edited=”on|tablet” border_width_bottom_tabs_item_active_tablet=”” border_width_bottom_tabs_item_active_phone=”2px” border_width_bottom_tabs_item_active_last_edited=”on|tablet” global_colors_info=”{}” custom_css_tabs_container_last_edited=”on|tablet” custom_css_tabs_container_tablet=”\/*width: 30% !important;||margin-right: 5px !important;*\/” custom_css_content_container_last_edited=”on|tablet” custom_css_content_container_tablet=”\/*width: 60% !important;*\/” custom_css_tabs_container_phone=”width: auto !important;” custom_css_content_container_phone=”width: auto !important;”][dipi_advanced_tabs_item title=”Sensibilisation du promoteur” is_default_tab=”on” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_1-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_1.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.18.0″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]<\/p>\n

Nous vous sensibilisons<\/span> aux bonnes pratiques cliniques<\/strong> et \u00e0 la r\u00e9glementation<\/strong> des investigations cliniques<\/span>, bases indispensables en tant que promoteur<\/strong>.<\/span><\/span>\u00a0<\/span><\/p>\n

[\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”S\u00e9lection des centres” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_2-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_2.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.18.0″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” global_colors_info=”{}”]<\/p>\n

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  • Identification<\/strong> et mobilisation<\/strong> de centres adapt\u00e9s \u00e0 votre \u00e9tude\u202f: \u00e9tablissements de sant\u00e9 ou bien professionnels de sant\u00e9 lib\u00e9raux.<\/span> <\/span><\/span><\/span><\/i><\/b><\/li>\n<\/ul>\n
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    Notre plus-value\u202f:<\/b> Notre r\u00e9seau m\u00e9dical et clinique contribue fortement \u00e0 la r\u00e9ussite de cette \u00e9tape\u202f!<\/span>\u00a0<\/span><\/span><\/p>\n<\/div>\n

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    • S\u00e9lection des centres investigateurs<\/strong><\/span>\u00a0<\/span><\/li>\n
    • Contractualisation<\/strong>\u202favec les investigateurs<\/span>\u00a0<\/span><\/li>\n<\/ul>\n

      <\/span><\/p>\n

      Quels crit\u00e8res de s\u00e9lection utilise-t-on pour \u00e9valuer un centre\u202favant s\u00e9lection ?<\/strong><\/div>\n

      [\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”Documentation clinique” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_3-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_3.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.19.1″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]<\/p>\n

      Construction, r\u00e9daction ou relecture<\/strong> des documents cliniques<\/strong> de l\u2019\u00e9tude demand\u00e9s par les autorit\u00e9s r\u00e9glementaires et n\u00e9cessaires au bon d\u00e9roulement de l\u2019investigation clinique :<\/span><\/p>\n

      <\/span><\/p>\n

        \n
      • Synopsis<\/strong> finalis\u00e9<\/span>\u00a0<\/span><\/li>\n
      • Protocole<\/strong> de l\u2019\u00e9tude (ou plan d\u2019investigation clinique)<\/span>\u00a0<\/span><\/li>\n
      • Plan d\u2019analyses statistiques<\/strong>\u00a0<\/span><\/li>\n
      • Processus<\/strong> de collecte et de traitement des donn\u00e9es<\/strong><\/span>\u00a0<\/span><\/li>\n
      • CRF<\/strong> (cahier d\u2019observation patient) ou eCRF<\/strong> (version digitale)<\/span><\/li>\n
      • Consentement<\/strong> ou e-consentement<\/strong> (version digitale)<\/span><\/li>\n
      • Note d\u2019information<\/strong>\u00a0<\/span><\/li>\n
      • Classeurs<\/strong> investigateurs<\/span>\u00a0<\/span><\/li>\n
      • Brochure investigateur\u00a0<\/strong><\/li>\n
      • Livrables :<\/span><\/b> ensemble de la documentation clinique<\/strong> pour r\u00e9aliser vos soumissions r\u00e9glementaires<\/strong><\/span>\u00a0<\/span><\/li>\n<\/ul>\n

        [\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”Soumissions r\u00e9glementaires” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_4-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_4.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.18.0″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]<\/p>\n

          \n
        • Collection of the elements required by the clinical trial regulations<\/span> <\/span><\/li>\n
        • Submissions and declarations<\/strong> to the relevant authorities (CNIL\/HDH, ANSM, CPP, CNOM, etc.)<\/span> <\/span><\/li>\n
        • Response to any questions and exchanges<\/strong> with the authorities<\/span><\/span><\/li>\n<\/ul>\n

          <\/span><\/p>\n

            \n
          • Deliverables :<\/span><\/b> regulatory approvals<\/strong> (favorable opinion) to launch your study<\/span> <\/span><\/li>\n<\/ul>\n

            [\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”Coordination de l’\u00e9tude” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_5-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_5.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.18.0″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]<\/p>\n

            Supervise the implementation of the clinical investigation<\/strong> in accordance with the schedule and budget, while ensuring the proper reporting of data.<\/span><\/p>\n

              \n
            • Implementation<\/strong> of the study in clinical investigation centers and\/or private practices<\/span> <\/span><\/li>\n
            • Operational follow-up<\/strong> of the study<\/span> <\/span><\/li>\n
            • Coordination<\/strong> of all stakeholders<\/span> <\/span><\/li>\n
            • Management<\/strong> of subcontractors<\/span> <\/span><\/li>\n
            • Regular follow-up meetings<\/strong> with the Sponsor<\/span> <\/span><\/li>\n
            • Administrative management<\/strong> (indemnification of SDB and patients, verification and payment of hospital costs and surcharges, etc.)<\/span> <\/span><\/li>\n<\/ul>\n

              [\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”Monitoring & management des sites” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_6-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_6.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.18.0″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]Suivre la r\u00e9alisation <\/strong>de l\u2019investigation clinique en conformit\u00e9<\/strong> avec le protocole, les bonnes pratiques cliniques ainsi que les obligations r\u00e9glementaires en vigueur<\/span>\u00a0<\/span><\/p>\n

                \n
              • Suivi de l\u2019avancement<\/strong> de l\u2019\u00e9tude<\/span><\/li>\n
              • Monitoring<\/strong> des donn\u00e9es collect\u00e9es<\/span>\u00a0<\/span><\/li>\n
              • Motivation<\/strong> des investigateurs et des centres participant \u00e0 l\u2019\u00e9tude.<\/span><\/li>\n<\/ul>\n
                L\u2019objectif est de booster le recrutement<\/strong> et d\u2019optimiser la dur\u00e9e de l\u2019\u00e9tude<\/strong> gr\u00e2ce \u00e0 un suivi rapproch\u00e9.<\/div>\n

                [\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”Data Management” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_7-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_7.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.19.1″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]<\/p>\n

                  \n
                • Structuration<\/strong> des donn\u00e9es cliniques dans la base de donn\u00e9es<\/strong> (eCRF)<\/span>\u00a0<\/span><\/li>\n
                • V\u00e9rification<\/strong> de la coh\u00e9rence et fiabilit\u00e9 des donn\u00e9es remont\u00e9es<\/span>\u00a0<\/span><\/li>\n
                • Nettoyage<\/strong> de la base de donn\u00e9es<\/span>\u00a0<\/span><\/li>\n<\/ul>\n
                    <\/ul>\n

                    [\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”Cl\u00f4ture de l’\u00e9tude clinique” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_8-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_8.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.19.1″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]<\/p>\n

                      \n
                    • Gel de la base<\/strong> de donn\u00e9es<\/span>\u00a0<\/span><\/li>\n
                    • Cl\u00f4ture<\/strong> des sites investigateurs<\/span>\u00a0<\/span><\/li>\n
                    • D\u00e9clarations<\/strong> de fin d\u2019\u00e9tude<\/span>\u00a0<\/span><\/li>\n
                    • Gestion et archivage<\/strong> de la documentation li\u00e9e \u00e0 l\u2019\u00e9tude<\/span>\u00a0<\/span><\/li>\n
                    • D\u00e9clarations l\u00e9gales<\/strong> li\u00e9es \u00e0 la r\u00e9mun\u00e9ration des professionnels de sant\u00e9<\/span>\u00a0<\/span><\/li>\n<\/ul>\n
                        <\/ul>\n

                        [\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”Analyses statistiques” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_9-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_9.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.18.0″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]<\/p>\n

                          \n
                        • Statistical analysis<\/strong> of the data according to the methodology defined in the statistical analysis plan<\/span> <\/span><\/li>\n
                        • Writing of the statistical report<\/strong><\/span> <\/span><\/li>\n
                        • Presentation of the statistical results<\/span><\/li>\n
                        • Deliverable :<\/span><\/b> statistical report<\/strong> of the study to write the clinical investigation report<\/span><\/li>\n<\/ul>\n

                          [\/dipi_advanced_tabs_item][dipi_advanced_tabs_item title=”Rapport d’investigation clinique” tab_media=”image” tab_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/GRIS_10-copie.png” use_active_tab_image=”on” tab_image_active=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/chiffres_10.png” tab_image_placement=”right” tab_image_size=”40px” _builder_version=”4.18.0″ _module_preset=”default” title_font=”||||||||” title_text_color=”#293540″ title_font_size=”20px” global_colors_info=”{}”]<\/p>\n

                            \n
                          • R\u00e9daction du rapport final de l\u2019investigation<\/strong> clinique<\/span>\u00a0<\/span><\/li>\n
                          • Pr\u00e9sentation des r\u00e9sultats aux investigateurs ayant particip\u00e9 \u00e0 l\u2019\u00e9tude<\/span><\/li>\n
                          • Livrable\u202f:<\/span><\/b> Rapport d\u2019investigation clinique<\/strong>\n
                            Il contient le rappel du protocole ainsi que la description et interpr\u00e9tation des r\u00e9sultats pour r\u00e9pondre aux objectifs de l\u2019\u00e9tude. En cas de marquage CE<\/strong>, ce rapport sera int\u00e9gr\u00e9 au dossier technique<\/strong> pour apporter la preuve scientifique de la performance et s\u00e9curit\u00e9 de votre dispositif<\/strong>.<\/div>\n<\/li>\n<\/ul>\n

                            [\/dipi_advanced_tabs_item][\/dipi_advanced_tabs][et_pb_accordion open_toggle_background_color=”RGBA(255,255,255,0)” closed_toggle_text_color=”#293540″ closed_toggle_background_color=”RGBA(255,255,255,0)” toggle_icon=”||fa||900″ icon_color=”#293540″ use_icon_font_size=”on” icon_font_size=”20px” disabled_on=”off|on|on” module_class=”pa-add-accordion-icon” _builder_version=”4.19.1″ _module_preset=”default” toggle_font=”|600|||||||” toggle_font_size=”23px” border_width_all=”0px” border_width_bottom=”2px” border_color_bottom=”#7FD072″ global_colors_info=”{}” icon_color__hover_enabled=”off|desktop”][et_pb_accordion_item title=”closed” open=”on” _builder_version=”4.19.1″ _module_preset=”default” custom_css_main_element=”display: none;” global_colors_info=”{}”][\/et_pb_accordion_item][et_pb_accordion_item title=”1. Promoter Awareness” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                            We make you aware of the good clinical practices<\/strong> and the regulation<\/strong> of clinical investigations, essential bases as a promoter<\/strong>.<\/p>\n

                            [\/et_pb_accordion_item][et_pb_accordion_item title=”2. Center Selection” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                              \n
                            • Identification<\/strong> and mobilization<\/strong> of centers adapted to your study: health institutions or liberal health professionals.<\/span> <\/span><\/span><\/span><\/i><\/b><\/li>\n<\/ul>\n
                              \n

                              Our added value<\/b> : Our medical and clinical network strongly contributes to the success of this step!<\/span> <\/span><\/span><\/p>\n<\/div>\n

                                \n
                              • Selection of investigator centers<\/strong><\/span> <\/span><\/li>\n
                              • Contractualization<\/strong> with investigators<\/span> <\/span><\/li>\n<\/ul>\n

                                <\/span><\/p>\n

                                What selection criteria are used to evaluate a center prior to selection?<\/strong><\/div>\n

                                [\/et_pb_accordion_item][et_pb_accordion_item title=”3. Clinical Documentation” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                                Construction, writing or proofreading<\/strong> of the clinical documents<\/strong> of the study requested by the regulatory authorities and necessary for the proper conduct of the clinical investigation:<\/span><\/p>\n

                                <\/span><\/p>\n

                                  \n
                                • Finalized synopsis<\/strong><\/span> <\/span><\/li>\n
                                • Study protocol<\/strong> (or clinical investigation plan)<\/span> <\/span><\/li>\n
                                • Statistical analysis plan<\/strong> <\/span><\/li>\n
                                • Data<\/strong> collection and treatment process<\/strong><\/span> <\/span><\/li>\n
                                • CRF<\/strong> (case report form) or eCRF<\/strong> (digital version)<\/span><\/li>\n
                                • Consent<\/strong> or e-consent<\/strong> (digital version)<\/span><\/li>\n
                                • Information note<\/strong> <\/span><\/li>\n
                                • Investigator binders<\/span> <\/span><\/li>\n
                                • Investigator brochure <\/strong><\/li>\n
                                • Deliverables:<\/span><\/b>all the clinical documentation<\/strong> to make your regulatory submissions<\/strong><\/span> <\/span><\/li>\n<\/ul>\n

                                  [\/et_pb_accordion_item][et_pb_accordion_item title=”4. Regulatory filings” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                                    \n
                                  • Recueil des \u00e9l\u00e9ments requis par la r\u00e9glementation des essais cliniques<\/span>\u00a0<\/span><\/li>\n
                                  • Soumissions et d\u00e9clarations aux instances<\/strong> concern\u00e9es (CNIL\/HDH, ANSM, CPP, CNOM\u2026)<\/span>\u00a0<\/span><\/li>\n
                                  • R\u00e9ponse aux \u00e9ventuelles questions et \u00e9changes<\/strong> avec les autorit\u00e9s<\/span><\/span><\/li>\n<\/ul>\n

                                    <\/span><\/p>\n

                                      \n
                                    • Livrables\u202f:<\/span><\/b> autorisations r\u00e9glementaires<\/strong> (avis favorable) pour lancer votre \u00e9tude<\/span>\u00a0<\/span><\/li>\n<\/ul>\n

                                      [\/et_pb_accordion_item][et_pb_accordion_item title=”5. Study coordination” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                                      Superviser la r\u00e9alisation de l\u2019investigation clinique<\/strong> dans le respect du calendrier et du budget, tout en veillant \u00e0 la bonne remont\u00e9e des donn\u00e9es.<\/span><\/p>\n

                                        \n
                                      • Mise en place<\/strong> de l\u2019\u00e9tude dans les centres d\u2019investigations cliniques et\/ou cabinets priv\u00e9s<\/span>\u00a0<\/span><\/li>\n
                                      • Suivi op\u00e9rationnel<\/strong> de l\u2019\u00e9tude<\/span>\u00a0<\/span><\/li>\n
                                      • Coordination<\/strong> de l\u2019ensemble des intervenants<\/span>\u00a0<\/span><\/li>\n
                                      • Gestion<\/strong> des sous-traitants<\/span>\u00a0<\/span><\/li>\n
                                      • R\u00e9unions<\/strong> r\u00e9guli\u00e8res de suivi avec le Promoteur<\/span>\u00a0<\/span><\/li>\n
                                      • Gestion administrative<\/strong> (indemnisations des PDS et patients, v\u00e9rification et r\u00e8glement des co\u00fbts et surco\u00fbts hospitaliers, …)<\/span>\u00a0<\/span><\/li>\n<\/ul>\n

                                        [\/et_pb_accordion_item][et_pb_accordion_item title=”6. Monitoring and management of sites” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                                        Follow the realization<\/strong> of the clinical investigation in accordance<\/strong> with the protocol, the good clinical practices and the regulatory obligations in force<\/span> <\/span><\/p>\n

                                          \n
                                        • Monitoring the progress<\/strong> of the study<\/span><\/li>\n
                                        • Monitoring<\/strong> of the data collected<\/span> <\/span><\/li>\n
                                        • Motivation<\/strong> of investigators and centers participating in the study.<\/span><\/li>\n<\/ul>\n
                                          The objective is to boost recruitment<\/strong> and optimize the duration of the study<\/strong> through close follow-up.<\/div>\n

                                          [\/et_pb_accordion_item][et_pb_accordion_item title=”7. Data Management” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                                            \n
                                          • Structuring<\/strong> of clinical data in the database<\/strong> (eCRF)<\/span> <\/span><\/li>\n
                                          • Verification<\/strong> of the consistency and reliability of the data returned<\/span> <\/span><\/li>\n
                                          • Cleaning<\/strong> of the database<\/span> <\/span><\/li>\n<\/ul>\n

                                            [\/et_pb_accordion_item][et_pb_accordion_item title=”8. Closure of clinical study” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                                              \n
                                            • Database freeze<\/strong><\/span> <\/span><\/li>\n
                                            • Closure<\/strong> of investigator sites<\/span> <\/span><\/li>\n
                                            • End of study reporting<\/strong><\/span> <\/span><\/li>\n
                                            • Management and archiving<\/strong> of study documentation<\/span> <\/span><\/li>\n
                                            • Legal declarations<\/strong> related to the remuneration of health professionals<\/span> <\/span><\/li>\n<\/ul>\n

                                              [\/et_pb_accordion_item][et_pb_accordion_item title=”9. Statistical analysis” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                                                \n
                                              • Analyses statistiques<\/strong> des donn\u00e9es selon la m\u00e9thodologie d\u00e9finie dans le plan d\u2019analyses statistiques<\/span>\u00a0<\/span><\/li>\n
                                              • R\u00e9daction du rapport statistique<\/strong><\/span>\u00a0<\/span><\/li>\n
                                              • Pr\u00e9sentation des r\u00e9sultats statistiques<\/span><\/li>\n
                                              • Livrable\u202f:<\/span><\/b> rapport statistique<\/strong> de l\u2019\u00e9tude pour r\u00e9diger le rapport d\u2019investigation clinique<\/span><\/li>\n<\/ul>\n

                                                [\/et_pb_accordion_item][et_pb_accordion_item title=”10. Clinical investigation report” icon_color=”#293540″ toggle_icon=”||fa||900″ _builder_version=”4.19.1″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n

                                                  \n
                                                • Writing of the final report of the clinical investigation<\/strong><\/span> <\/span><\/li>\n
                                                • Presentation of the results to the investigators who participated in the study<\/span><\/li>\n
                                                • Deliverable : <\/span><\/b>Clinical investigation report <\/strong>\n
                                                  It contains a reminder of the protocol as well as the description and interpretation of the results to meet the objectives of the study. In case of CE marking<\/strong>, this report will be included in the technical file<\/strong> to provide scientific proof of the performance and safety of your device<\/strong>.<\/div>\n<\/li>\n<\/ul>\n

                                                  [\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                                                  Different themes complementary to those discussed below must be addressed to conduct a clinical study in its entirety:<\/strong><\/p>\n

                                                  [\/et_pb_text][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”500ms” global_colors_info=”{}”]<\/p>\n

                                                  Material (pharmaco) vigilance<\/strong><\/p>\n

                                                  [\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”600ms” global_colors_info=”{}”]<\/p>\n

                                                  Digital tools<\/strong> used to collect data in real life (ePRO<\/strong>), structure them (eCRF<\/strong>) or facilitate the recruitment process (e-consent<\/strong>)<\/p>\n

                                                  [\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”700ms” global_colors_info=”{}”]<\/p>\n

                                                  Monitoring<\/strong> by a CRA<\/strong> (Clinical Research Associate)<\/p>\n

                                                  [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.17.4″ _module_preset=”default” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/the-doctor-makes-magnetic-resonance-therapy-Grand-1024×683.jpg” title_text=”City of Gomel, Belarus 31 May 2017.City hospital. The doctor makes magnetic resonance therapy. Medical examination of the body. Computer diagnosis of the brain” _builder_version=”4.17.6″ _module_preset=”a1ca4c43-39cf-4674-8db0-cf5c7d50981f” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.6″ _module_preset=”default” width_tablet=”80%” width_phone=”80%” width_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”d4b4e832-696b-4521-820b-303d99dd66ae” global_colors_info=”{}”]<\/p>\n

                                                  KYomed INNOV has built a network of qualified and complementary partners and subcontractors<\/strong> in order to accompany<\/strong> you in a global<\/strong> way on the conduct of your clinical investigation<\/strong>, by integrating all aspects.<\/p>\n

                                                  [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=”off|off|off” _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider show_divider=”off” disabled_on=”off|off|off” _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][et_pb_button button_url=”#contact” button_text=”I need help to supervise or carry out my clinical investigation” _builder_version=”4.18.0″ _module_preset=”a791ea40-b723-47fd-9c77-c58bf4d3d46c” transform_translate_linked__hover=”off” global_colors_info=”{}” transform_translate__hover=”0px|-5px”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_id=”scac” _builder_version=”4.18.0″ _module_preset=”_initial” background_enable_image=”off” top_divider_height=”40px” top_divider_flip=”vertical” bottom_divider_flip=”horizontal” global_colors_info=”{}”][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider _builder_version=”4.17.4″ _module_preset=”2f02c485-6fbd-444b-8389-5d5a1aca54f6″ global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.18.0″ _module_preset=”0294cc11-a8bb-4cff-a429-6bb8a3a07242″ global_colors_info=”{}”]<\/p>\n

                                                  Post-Market Clinical Follow-up (PMCF)<\/h2>\n

                                                  [\/et_pb_text][et_pb_text _builder_version=”4.19.1″ _module_preset=”0c90df4f-8445-4953-8b21-6914f398f2de” global_colors_info=”{}”]<\/p>\n

                                                  For a medical device that is always efficient, safe, and compliant with current standards.<\/h3>\n

                                                  [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” custom_padding_last_edited=”on|phone” _builder_version=”4.19.0″ _module_preset=”default” custom_padding_tablet=”” custom_padding_phone=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                                                  Post-market clinical<\/strong> follow-up is a mandatory step<\/strong> for your device after it has been put on the market<\/strong>.
                                                  It consists of a systematic procedure for proactively collecting real-life<\/strong> data to quickly consider any new preventive or corrective measures<\/strong> on your medical device.<\/p>\n

                                                  [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.6″ _module_preset=”default” width_tablet=”80%” width_phone=”80%” width_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”a1d074ca-e2d0-4ab2-b4b2-9e769390c7d8″ global_colors_info=”{}”]<\/p>\n

                                                  The PMCF plan<\/strong> is part of the CE marking file<\/strong>, so it must be anticipated as soon as your file is prepared.<\/p>\n

                                                  [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ make_equal=”on” module_class=”inverse” _builder_version=”4.17.4″ _module_preset=”default” custom_margin=”20px||20px||true|false” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.17.4″ _module_preset=”default” custom_padding_tablet=”50px||||false|false” custom_padding_phone=”50px||||false|false” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/schema.png” title_text=”sch\u00e9ma” show_in_lightbox=”on” _builder_version=”4.18.0″ _module_preset=”9c5756ed-db6f-4c03-91bf-dad672dfea85″ box_shadow_horizontal_tablet=”” box_shadow_horizontal_phone=”-10px” box_shadow_horizontal_last_edited=”on|phone” box_shadow_vertical_tablet=”” box_shadow_vertical_phone=”10px” box_shadow_vertical_last_edited=”on|phone” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                                                  This step should be planned before your certification<\/strong> because it is essential to comply with the regulations<\/strong> in force. This is now part of the obligations<\/strong> associated with the CE marking<\/strong> of a medical device.<\/p>\n

                                                  The PMCF<\/strong> is an integral part of the PMS : Post-Market Surveillance<\/strong> which is more global and contains other regulatory and normative aspects in addition to the clinical part.<\/p>\n

                                                  [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_3,1_3″ make_equal=”on” _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”2_3″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                                                  The PMCF<\/strong> is linked to your clinical strategy<\/strong>, so it allows you to be proactive<\/strong> and think about the different points to check and validate when your device will be used by your future users in real life<\/strong>.<\/p>\n

                                                  The PMCF will therefore extend throughout the life cycle of your device<\/strong> and will, using new clinical data collected in real life, allow to:<\/p>\n

                                                  [\/et_pb_text][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”500ms” global_colors_info=”{}”]<\/p>\n

                                                  Confirm safety<\/strong> and performance<\/strong>(s)<\/p>\n

                                                  [\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”600ms” global_colors_info=”{}”]<\/p>\n

                                                  Monitor side effects<\/strong> and contraindications<\/strong><\/p>\n

                                                  [\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”700ms” global_colors_info=”{}”]<\/p>\n

                                                  Identify emerging risks<\/strong><\/p>\n

                                                  [\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”800ms” global_colors_info=”{}”]<\/p>\n

                                                  Identify any misuse<\/strong><\/p>\n

                                                  [\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”900ms” global_colors_info=”{}”]<\/p>\n

                                                  Confirm the benefit\/risk ratio<\/strong><\/p>\n

                                                  [\/et_pb_blurb][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”20px||||false|false” global_colors_info=”{}”]<\/p>\n

                                                  It also allows you to have a long term vision<\/strong> for your solution through the next planned evolutions<\/strong>, the related studies and eventually the strategic perspectives<\/strong> such as going for a refund.<\/p>\n

                                                  [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.17.4″ _module_preset=”default” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/office-worker-using-fingertip-oximeter-at-office-Grand-1024×683.jpg” title_text=”Office worker using fingertip oximeter at office” _builder_version=”4.17.6″ _module_preset=”a1ca4c43-39cf-4674-8db0-cf5c7d50981f” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_image_width=”40%” background_position=”bottom_right” background_horizontal_offset=”3%” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipi_text_highlighter text_highlighter_text=”Plan de SCAC avant certification” highlight_shape=”strikethrough” text_wrapper_tag=”h3″ highlight_animation_repeat_mode=”definite” _builder_version=”4.17.6″ _module_preset=”f0508cbb-f909-49fb-96e4-4ab87c30e9cf” global_colors_info=”{}”][\/dipi_text_highlighter][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                                                  During the preparation of your CE marking file<\/strong>, we assist<\/strong> you in the construction of this PMCF plan<\/strong> in order to anticipate<\/strong> and plan<\/strong> the studies or data collection to come, following the marketing of your device.<\/p>\n

                                                  [\/et_pb_text][et_pb_blurb title=”Deliverables :” image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icone_livrables-2.png” _builder_version=”4.18.0″ _module_preset=”99d736ba-ec92-4cf8-878c-35f6a34a30ab” animation_delay=”500ms” global_colors_info=”{}”]<\/p>\n

                                                  Planning<\/strong> of the PMCF(s)<\/strong> and follow-up of preventive and corrective actions decided upstream.<\/p>\n

                                                  [\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][dipi_text_highlighter text_highlighter_text=”R\u00e9alisation ou suivi du SCAC apr\u00e8s mise sur le march\u00e9” highlight_shape=”strikethrough” text_wrapper_tag=”h3″ highlight_animation_repeat_mode=”definite” _builder_version=”4.19.0″ _module_preset=”f0508cbb-f909-49fb-96e4-4ab87c30e9cf” global_colors_info=”{}”][\/dipi_text_highlighter][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                                                  In a second step, we accompany you in the formalization<\/strong> and implementation of these clinical procedures<\/strong>. This can be :<\/p>\n

                                                  [\/et_pb_text][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”500ms” global_colors_info=”{}”]<\/p>\n

                                                  A clinical study<\/strong><\/p>\n

                                                  [\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”600ms” global_colors_info=”{}”]<\/p>\n

                                                  A medico-economic study<\/strong> with the objective of obtaining reimbursement<\/p>\n

                                                  [\/et_pb_blurb][et_pb_blurb image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icones_puce-2-copie.png” _builder_version=”4.18.0″ _module_preset=”e16d86b9-e522-4803-b8db-4844d1f5de3a” animation_duration=”1500ms” animation_delay=”700ms” global_colors_info=”{}”]<\/p>\n

                                                  A registry<\/strong><\/p>\n

                                                  [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.17.4″ _module_preset=”default” custom_css_main_element=”margin: auto;” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/composite-image-of-digital-composite-of-heart-icon-Grand-1024×683.jpg” title_text=”Digital composite of heart icon against man pointing over smart watch” _builder_version=”4.17.6″ _module_preset=”7b8db442-b654-4253-a145-2bb889cd02ce” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row make_equal=”on” _builder_version=”4.17.6″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_position=”top_left” background_horizontal_offset=”-3%” background_vertical_offset=”-100%” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                                                  For each of the procedures chosen in the PMCF plan<\/strong>, you will have to work on the methodology and design of the study to be set up, in the same way as for any clinical investigation methodology<\/strong> and design.<\/strong> Then, depending on the schedule defined after the marketing<\/strong> of your device, you will be able to launch your planned procedures.<\/p>\n

                                                  [\/et_pb_text][et_pb_blurb title=”Deliverables :” image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/07\/icone_livrables-2.png” _builder_version=”4.18.0″ _module_preset=”99d736ba-ec92-4cf8-878c-35f6a34a30ab” global_colors_info=”{}”]<\/p>\n

                                                  Methodology <\/span><\/strong>and design<\/strong><\/span> <\/span>of the PMCF <\/span>and then conduct of the study<\/strong> with a clinical investigation report at the end<\/span>.<\/p>\n

                                                  [\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”#contact” button_text=”I need help to build or realize my PMCF” button_alignment_tablet=”” button_alignment_phone=”” button_alignment_last_edited=”on|desktop” _builder_version=”4.18.0″ _module_preset=”a791ea40-b723-47fd-9c77-c58bf4d3d46c” custom_margin=”30px||||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|tablet” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_id=”faq” _builder_version=”4.18.0″ _module_preset=”34a86d6c-a6ae-4c46-8166-be640ef83b27″ background_image=”https:\/\/www.kyomedinnov.com\/wp-content\/uploads\/2022\/09\/CRO-clinique-gris-2.svg” background_image_width=”20%” background_position=”center_right” background_horizontal_offset=”-3%” custom_margin=”||100px||false|false” global_colors_info=”{}”][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider divider_weight=”4px” _builder_version=”4.17.4″ _module_preset=”2f02c485-6fbd-444b-8389-5d5a1aca54f6″ global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.17.6″ _module_preset=”0294cc11-a8bb-4cff-a429-6bb8a3a07242″ global_colors_info=”{}”]<\/p>\n

                                                  FAQ – Frequently asked questions<\/h2>\n

                                                  [\/et_pb_text][dipi_faq faq_categories=”13″ accordion_open_first=”off” icon_open_font_size=”25px” icon_closed_font_size=”25px” _builder_version=”4.19.1″ _module_preset=”9a991805-9d52-4d8c-917d-9d8e89521bc1″ title_open_text_color=”#293540″ global_colors_info=”{}”][\/dipi_faq][et_pb_button button_url=”https:\/\/www.kyomedinnov.com\/en\/our-projects\/#cro-clinique” button_text=”The solutions we support” _builder_version=”4.18.0″ _module_preset=”a791ea40-b723-47fd-9c77-c58bf4d3d46c” custom_margin=”50px||||false|false” global_colors_info=”{}”][\/et_pb_button][dipi_faq _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][\/dipi_faq][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ next_background_color=”#293540″ module_id=”contact” _builder_version=”4.19.0″ _module_preset=”34a86d6c-a6ae-4c46-8166-be640ef83b27″ background_enable_image=”off” background_horizontal_offset=”-3%” background_vertical_offset=”68%” background_blend=”difference” bottom_divider_style=”none” global_module=”28396″ saved_tabs=”all” global_colors_info=”{}”][et_pb_row _builder_version=”4.17.4″ _module_preset=”default” custom_padding=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.17.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider color=”#00B9F2″ divider_position=”center” divider_weight=”4px” _builder_version=”4.17.4″ _module_preset=”default” width=”10%” width_tablet=”20%” width_phone=”” width_last_edited=”on|tablet” border_radii=”on|1px|1px|1px|1px” global_colors_info=”{}” width__hover_enabled=”off|desktop”][\/et_pb_divider][et_pb_text _builder_version=”4.19.0″ _module_preset=”0294cc11-a8bb-4cff-a429-6bb8a3a07242″ global_colors_info=”{}”]<\/p>\n

                                                  Contact us<\/h2>\n

                                                  [\/et_pb_text][et_pb_text _builder_version=”4.19.0″ _module_preset=”0c90df4f-8445-4953-8b21-6914f398f2de” global_colors_info=”{}”]<\/p>\n

                                                  If you have a digital health project, our entire team is here to help you.<\/h3>\n

                                                  [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ custom_padding_last_edited=”on|phone” _builder_version=”4.19.4″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.19.4″ _module_preset=”default” custom_padding=”|50px|||false|false” custom_padding_tablet=”” custom_padding_phone=”|0px|||false|false” custom_padding_last_edited=”on|phone” border_width_right=”2px” border_color_right=”#144C81″ border_width_all_tablet=”” border_width_all_phone=”” border_width_all_last_edited=”on|tablet” border_width_right_tablet=”0px” border_width_right_phone=”” border_width_right_last_edited=”on|desktop” global_colors_info=”{}” custom_css_main_element_last_edited=”off|tablet”][et_pb_contact_form email=”contact@kyomed.com” success_message=”Your message has been 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                                                  Strategy, Methodology and Clinical InvestigationsKYomed INNOV is a clinical CRO (Clinical Research Organization) specialized in digital health. We support you in the realization of your clinical objectives, through all phases of your clinical roadmap. We intervene from the construction of your clinical development strategy, to the elaboration of a methodology and design for your clinical […]<\/p>\n","protected":false},"author":2,"featured_media":30606,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"dipi_cpt_category":[],"class_list":["post-53790","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/pages\/53790","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/comments?post=53790"}],"version-history":[{"count":0,"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/pages\/53790\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/media\/30606"}],"wp:attachment":[{"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/media?parent=53790"}],"wp:term":[{"taxonomy":"dipi_cpt_category","embeddable":true,"href":"https:\/\/www.kyomedinnov.com\/en\/wp-json\/wp\/v2\/dipi_cpt_category?post=53790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}