Data compliance for organizations conducting clinical trials.

Clinical trial compliance is all about reconciling clinical trials with the GDPR. This includes framing data processing, supervising the various data transfers, applying the rights of data subjects and dealing with the relevant national authorities. The objective is to ensure, within the meaning of the GDPR, the implementation of the clinical study. This is done by supporting all parties in applying the legal and regulatory requirements linked to data protection.

In the form of project management, we hold a scoping meeting from which we determine an action plan that we prioritize for you. We then qualify the parties and propose appropriate agreements. Our actions are based on a deployment logic to meet your deadlines. You need to check whether the GDPR applies to the study in question. If the latter applies, we need to define the type of research to be carried out, and check under which regime it will be carried out. That is, does the research in question fall under the regime of a declaration of compliance with a reference methodology or under the regime of prior authorization. An in-depth study of the Research Protocol, established research contracts or any other document relating to the study should be carried out, in order to prepare for adequate compliance

In order to verify the compliance of your clinical trials, we use the European GDPR regulation. This is binding for both organizations established in the EU that processes personal data (both on its on behalf and not), as well as organizations established outside of the EU that are targeting European residents.

We also have the possibility, when the case arises, to check national laws when the GDPR cannot be applied in the deployment of your clinical trial.

The legal and regulatory framework is determined on a case-by-case basis according to the design of the respective research project.
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Clinical trials are subject to a regulatory prism impacting health law, data protection law and exploitation rights. Depending on the project, the data collected, compiled, used (via AI, for example) or transferred, may be subject to requests for authorization or declaration of conformity from European or national authorities (CNIL, FDA, ANSM, EMA, ethical standards outlined in the Declaration of Helsinki, etc.).
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In the European Union, this involves determining the applicable reference methodology with regard to:

1. Whether or not the research involves human persons (Research Involving the Human Person – « RIPH ») or not (use of products of the human body)

2. Whether or not the research is interventional (modification of care in order to carry out the research)

3. Whether the research requires the use of specific technologies or materials, etc.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.