The clinical development of new compounds is an exciting phase of innovation for Sanofi’s research teams, one that involves conducting clinical trials to verify that new treatments are effective and safe for patients. We are strongly committed to compliance with international standards during product development to guarantee the welfare of trial participants, the reliability of collected clinical data and respect for ethics in the conduct of studies. In line with our commitment to transparency, we publicly disclose appropriate information about clinical study protocols and the results of our clinical trials. All our clinical trials are carried out in accordance with the fundamental principles of ethics and full transparency with respect to study protocols and trial results. Sanofi’s commitment is based on:

  • Free and informed consent of clinical trial participants

Participants’ consent must be given prior to any procedure or any change in the procedures of an ongoing study and before any data are collected.

  • Compliance with international standards and local legislation

Before beginning a clinical study, we ensure that the trial protocol complies with international regulations and applicable local legislation in the country where the trial is being conducted. In resource-poor settings, we pay particular attention to upholding the rules of ethics during recruitment of trial participants.

In all countries across the globe, Sanofi employees and investigators involved in clinical trials receive training about compliance with international standards and regulations.

  • Communicating reliable information about the trial protocol to health authorities

Sanofi will only initiate clinical trials that have received a favorable assessment by the health authorities and an independent ethics committee. In countries without ethics committees, a French committee that includes stakeholders from the country where the trial is being conducted reviews the trial protocol and procedures before Sanofi begins the trial.

Internal audits

We conduct internal audits of our clinical trials and associated information systems on a regular basis as a means of ensuring continuous improvement of our practices. For certain clinical trials, we may outsource clinical operations locally to clinical research organizations, which are also subject to audits by our teams. The purpose of these audits is to ensure strict compliance with Good Clinical Practices.

Sanofi Research and Development Ethics

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