Strategy, Methodology and Clinical Investigations
KYomed 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 study until the realization of your clinical study in pre or post-marketing.
Our team of specialists will be able to help you whatever your objectives are for your solution:
Collect initial clinical data
Demonstrate your claims scientifically
Demonstrate performance and safety for CE marking
Demonstrate the medico-economic impact for possible reimbursement
Monitor real-life use once your product is on the market
Demonstrate the impact even if you do not want to be a Medical Device
To optimize the duration and costs of your clinical phases, our clinical team supports you at each step of your roadmap to anticipate your needs and reinforce the quality of your results while meeting regulatory requirements.
We are specialized in digital medical devices and more globally in health technologies.
Different expertise is needed to conduct a clinical study in its entirety.
This is why KYomed INNOV has built a network of qualified and complementary partners and subcontractors in order to accompany you in a global way in your clinical development, by integrating all aspects.
The benefits?
A single contact for your study: your dedicated clinical project manager
An assurance on the quality of the work provided by the partners/subcontractors of your clinical study.
Time saving in your search for stakeholders and in contracting.
Expert supervision of stakeholders
Stakeholders for your study who know each other and are used to working and exchanging with each other.
Methodology and Clinical Design
According to your objectives and your strategy in order to optimize the costs and duration of your clinical phases.
Clinical Investigation
Demonstrate the performance and safety of your medical device.
Post-market clinical follow-up
For a medical device that is always efficient, safe and compliant with current standards.
Strategy, Methodology and Clinical Investigations
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.
With more than 8 years of experience in real-life clinical trials and with an experienced team, the methodologies and clinical designs co-constructed manage to blend your strategic objectives, the scientific knowledge on the pathology concerned, the use of real-life data (RWD, RWE, PROMS, PREMS) and the regulation of clinical trials.
It is this balance that is recognized and allows us to build a solid foundation to make your project a success.
We will first discuss your clinical development strategy with you to identify the clinical roadmap of your project. If you have already worked on your clinical strategy, we will build on your work and optimize it if necessary. Otherwise, we will start from a blank page and build it together.
For this we will analyze all the information related to your device:
Its step of development
Your market access strategy
Your business model
The applicable regulations
Targeted markets
The care pathway(s)
Literature on the subject (incidence, epidemiology, eligible population and recruitment)
Possible competing or complementary solutions
To deal with each of these aspects, we will build a team around your project that will be composed of our experts but also of experts from our network.
We will propose personalized services according to different criteria (size of your company, deadlines, budgets…) but also to the type of expertise you need (market access, regulatory, vigilance…).
Our clinical project managers, methodologists and statisticians will then meet with your team (sponsor and specialized healthcare professional) to define together the primary and secondary objectives to build the design of your clinical study in line with your requirements.
We will base our work on the data in the literature or on any existing clinical data on your device.
We will assist you in determining :
The type of study adapted methodologically
The primary and secondary objectives
The evaluation criteria
The number of subjects required (NSN)
The duration of the study
Investigator site(s)
Study population (inclusion and non-inclusion criteria)
Anticipated study schedule
Recruitment process
Regulatory submissions required for the study
Deliverable :
At the end of this step, we will provide you with a draft synopsis that will allow you to establish and concretize the methodology and design of your study.
Next step?
The construction and writing of all the clinical documentation for your study to make your regulatory submissions and obtain the authorizations to launch this study.
For each project we support, KYomed INNOV applies its quality approach so that your clinical investigation is designed and carried out in accordance with the regulations in force.
We can also involve a regulatory expert to refine the positioning of your solution to avoid being a medical device or to see how to optimize its classification.
Clinical investigation
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.
What is the difference between a clinical investigation, a clinical study, a clinical trial, and clinical evaluation?
Clinical investigation, clinical study and clinical trial are synonymous terms. They refer to a systematic investigation involving one or more human subjects, undertaken to verify the safety or performance of a medical device.
However, clinical evaluation 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.
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, management and supervision of your clinical investigation..
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.
Clinical investigation
A clinical investigation is a process that takes place in 10 steps, which we can accompany you through, depending on your resources and your internal skills.
Nous vous sensibilisons aux bonnes pratiques cliniques et à la réglementation des investigations cliniques, bases indispensables en tant que promoteur.
- Identification et mobilisation de centres adaptés à votre étude : établissements de santé ou bien professionnels de santé libéraux.
Notre plus-value : Notre réseau médical et clinique contribue fortement à la réussite de cette étape !
- Sélection des centres investigateurs
- Contractualisation avec les investigateurs
Construction, rédaction ou relecture des documents cliniques de l’étude demandés par les autorités réglementaires et nécessaires au bon déroulement de l’investigation clinique :
- Synopsis finalisé
- Protocole de l’étude (ou plan d’investigation clinique)
- Plan d’analyses statistiques
- Processus de collecte et de traitement des données
- CRF (cahier d’observation patient) ou eCRF (version digitale)
- Consentement ou e-consentement (version digitale)
- Note d’information
- Classeurs investigateurs
- Brochure investigateur
- Livrables : ensemble de la documentation clinique pour réaliser vos soumissions réglementaires
- Collection of the elements required by the clinical trial regulations
- Submissions and declarations to the relevant authorities (CNIL/HDH, ANSM, CPP, CNOM, etc.)
- Response to any questions and exchanges with the authorities
- Deliverables : regulatory approvals (favorable opinion) to launch your study
Supervise the implementation of the clinical investigation in accordance with the schedule and budget, while ensuring the proper reporting of data.
- Implementation of the study in clinical investigation centers and/or private practices
- Operational follow-up of the study
- Coordination of all stakeholders
- Management of subcontractors
- Regular follow-up meetings with the Sponsor
- Administrative management (indemnification of SDB and patients, verification and payment of hospital costs and surcharges, etc.)
- Suivi de l’avancement de l’étude
- Monitoring des données collectées
- Motivation des investigateurs et des centres participant à l’étude.
- Structuration des données cliniques dans la base de données (eCRF)
- Vérification de la cohérence et fiabilité des données remontées
- Nettoyage de la base de données
- Gel de la base de données
- Clôture des sites investigateurs
- Déclarations de fin d’étude
- Gestion et archivage de la documentation liée à l’étude
- Déclarations légales liées à la rémunération des professionnels de santé
- Statistical analysis of the data according to the methodology defined in the statistical analysis plan
- Writing of the statistical report
- Presentation of the statistical results
- Deliverable : statistical report of the study to write the clinical investigation report
- Rédaction du rapport final de l’investigation clinique
- Présentation des résultats aux investigateurs ayant participé à l’étude
- Livrable : Rapport d’investigation clinique
Il contient le rappel du protocole ainsi que la description et interprétation des résultats pour répondre aux objectifs de l’étude. En cas de marquage CE, ce rapport sera intégré au dossier technique pour apporter la preuve scientifique de la performance et sécurité de votre dispositif.
Different themes complementary to those discussed below must be addressed to conduct a clinical study in its entirety:
Material (pharmaco) vigilance
Digital tools used to collect data in real life (ePRO), structure them (eCRF) or facilitate the recruitment process (e-consent)
Monitoring by a CRA (Clinical Research Associate)
KYomed INNOV has built a network of qualified and complementary partners and subcontractors in order to accompany you in a global way on the conduct of your clinical investigation, by integrating all aspects.
Post-Market Clinical Follow-up (PMCF)
For a medical device that is always efficient, safe, and compliant with current standards.
Post-market clinical follow-up is a mandatory step for your device after it has been put on the market.
It consists of a systematic procedure for proactively collecting real-life data to quickly consider any new preventive or corrective measures on your medical device.
The PMCF plan is part of the CE marking file, so it must be anticipated as soon as your file is prepared.
This step should be planned before your certification because it is essential to comply with the regulations in force. This is now part of the obligations associated with the CE marking of a medical device.
The PMCF is an integral part of the PMS : Post-Market Surveillance which is more global and contains other regulatory and normative aspects in addition to the clinical part.
The PMCF is linked to your clinical strategy, so it allows you to be proactive and think about the different points to check and validate when your device will be used by your future users in real life.
The PMCF will therefore extend throughout the life cycle of your device and will, using new clinical data collected in real life, allow to:
Confirm safety and performance(s)
Monitor side effects and contraindications
Identify emerging risks
Identify any misuse
Confirm the benefit/risk ratio
It also allows you to have a long term vision for your solution through the next planned evolutions, the related studies and eventually the strategic perspectives such as going for a refund.
During the preparation of your CE marking file, we assist you in the construction of this PMCF plan in order to anticipate and plan the studies or data collection to come, following the marketing of your device.
Deliverables :
Planning of the PMCF(s) and follow-up of preventive and corrective actions decided upstream.
In a second step, we accompany you in the formalization and implementation of these clinical procedures. This can be :
A clinical study
A medico-economic study with the objective of obtaining reimbursement
A registry
For each of the procedures chosen in the PMCF plan, 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 and design. Then, depending on the schedule defined after the marketing of your device, you will be able to launch your planned procedures.
Deliverables :
Methodology and design of the PMCF and then conduct of the study with a clinical investigation report at the end.
FAQ – Frequently asked questions
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