Collection of Patient Data under Real-life Conditions

A collection recommended by the health authorities

For evaluations of medical devices (MD), as for of pharmaceuticals, the health authorities recommend that the point of view of the patients concerned be taken into account. In particular, they recommend that patient data be collected under real-life conditions.

For an MD, this data provides information on its efficacy (for example, patient mobility, dexterity, etc.) or indeed anything else that could impact on efficacy (for example, the patients’ lifestyles, their environment, their treatment plan, etc.).

This real-life patient data can include:

– information declared by the patients themselves (referred to as Patient Reported Outcomes or PRO): as part of their real-life environment, patients describe their own symptoms, feelings, appreciation of their health and quality of life in relation to a course of therapy or hospital care, without this information being filtered through the lens of the staff involved in the care and likely therefore to have their own interpretation;

– digital data collected by connected devices or mobile applications.

KYomed INNOV’s ePRO, a tool dedicated to collecting real-time patient data

To facilitate the collection of patient-reported data during biomedical research, KYomed INNOV has developed a specific digital tool: ePRO (electronic Patient-Reported Outcomes). “Each investigator and clinical project manager can draw on this tool in order to add to his clinical evaluation a pool of data that patients will provide themselves by filling out questionnaires on our application,” explains the business development manager.

Using connected devices to generate new data

Another solution for collecting this data: connected devices. Through its continual in-depth monitoring of the connected health and autonomous living sectors, KYomed INNOV has complete cognizance of the market for devices capable of collecting this real-life conditions data.

Our unique position in connected health allows us to have a realistic and yet innovative perspective for achieving the evaluation’s goals. Our excellent knowledge of existing technologies and our ability to think outside the box enable us to consider a wide range of possibilities for addressing a given problem.

We are able to advise our clients on the most appropriate, and often the simplest, method of collecting relevant data in line with the objectives of their clinical evaluation.

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