Servier recognizes the importance of Investigator Initiated Trials (IITs) conducted by Third-Party Sponsors. For this purpose, Servier is committed to support medical and scientific research which contributes to better understand the Group’s therapeutic solutions as well as to explore new opportunities to address unmet patient medical needs.
Within Servier, and in response to an unsolicited request, Investigator Initiated Trials (IITs) are studies with scientific and medical rationale developed by an independent Third-Party Sponsor for which Servier provides support with funding and/or supply of Servier products.
They are also known as: Investigator Initiated Studies, Investigator Initiated Research or Investigator Sponsored Research
This guidance provides Servier policy and process relating to Third-Party Sponsored Studies.
Non-interventional* (e.g. disease understanding, drug usage) or interventional with products under development or already registered.
* for non-interventional studies, funding only might be provided.
By training and experience to undertake the proposed research and may include, but is not limited to institutions, academic or cooperative groups, or group of physicians.
The study remains independent and under the full responsibility of the Third-Party Sponsor. No undue influence nor operational support from any Servier employee will be provided to conduct or drive the study.
Roles and responsibilities of each party will be described in an agreement.
The Sponsor has the responsibilities for all aspects of the study as per ICH-GCP, including but not limited to:
As a Health Care Professional, you should contact your Servier Local Medical Affairs’ Representative in your country or ask for a Medical Representative in the Servier local country office. Documents you need to submit to the Servier Local Medical Affairs representative.
The study concept will be assessed internally by a Local Committee; if accepted, it will undergo review by a Global Review Committee. Study concept clarifications may be required by the respective committees at any stage of the review process. If the concept is approved, a contractual Agreement will take place.
Servier follows a strict code of ethics which ensures compliance with regulations and ethical standards. Research proposals are assessed according to Servier research areas of interest and strictly on their scientific merit and alignment with the Company´s overall research, global development strategy, assurance that conditions for patient safety are met.
Servier is committed to maintain Transparency and Integrity in all interactions with healthcare professionals.
As required by agreement and regulation, Servier discloses financial support provided to researchers and their institutions. Funding of research must not exceed local fair market value, nor be used for expenses not associated with the conduct of the research.
We thank you for soliciting Servier for your research project