Clinical Validation of Health Markers

Clinical validation is a crucial step in the development of health markers. It serves to demonstrate their effectiveness, and therefore their value, to health authorities and to health professionals.

The objectives of the clinical evaluation

The clinical validation phase aims to demonstrate, on the one hand, that the health marker has an additional value over and above the clinical data and tools already that have already been validated and are available on the market and, on the other, that the knowledge of the marker’s result improves the patient’s treatment (prognosis, duration of hospitalization …).

In other words, clinical validation provides evidence of the performance and safety of the health marker in a well-defined context of use. This precise context determines the nature of the regulatory requirements that the health marker must meet during the validation if it is to obtain market authorization.

For example, if a health marker (or a combination of health markers) is intended for use as a companion diagnosis, its clinical validation is required by the health authorities. “We are able to rely on regulatory experts to help us develop appropriate protocols that match the regulatory requirements”, says our Business Development Manager.

A double competence at the service of your project

For all other aspects, KYomed INNOV is able to rely on the expertise of its clinical evaluations and data analysis teams — their skills are indeed essential throughout the project. For each project entrusted to us, we create the appropriate dedicated team: a clinical evaluation project manager is responsible for conducting the necessary investigations, while a data mining project manager is responsible for analyzing the results of the study.

This combination of expertise in health markers, data analysis and clinical evaluations is what makes us so effective. It allows us to assist our clients right the way through their entire project, including the commercial launch.