Third-Party Sponsored Studies

Servier recognises the importance of Third-Party Sponsored Studies. For this purpose, Servier is committed to support medical and scientific research which contribute to better understand the Group’s therapeutic solutions related to its areas of interest and to explore new opportunities to address unmet patient medical needs.

Servier supports 2 types of study proposals:

Investigator Sponsored Studies (ISS): studies with scientific and medical rationale developed and conducted by an independent Third-Party Sponsor for which Servier only provides support with funding and/or supply of Servier product in response to an unsolicited request.
Collaborative Research Studies (CRS): studies with scientific and medical rationale conducted by an external sponsor (institution or organization) based on jointly defined research between Servier and the Sponsor.
Servier may contribute to study design and deliverables and provides support with funding and/or supply of product.

The Third-Party Study Sponsor is accountable for all aspects of the study as well as for complying with all applicable ethical, regulatory, transparency and legal requirements (including pharmacovigilance reporting).

This guidance provides Servier policy and process for Third-Party Sponsored Studies.

Eligible studies:

Interventional with products under development or already registered,
Non-interventional* (e.g. disease understanding, drug usage).

* for non-interventional studies, funding only might be provided.

Third-party sponsor must be qualified 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.

Servier does not accept study requests from individual physicians or groups of physicians in private practice.

Roles and responsibilities of each party will be described in an agreement.

What are the responsibilities of the Third-Party Sponsor?

The sponsor has the responsibilities for all aspects of the study, including but not limited to:

Writing independently (for ISS) the study concept with a strong rationale and submitting it to Servier for support request
Developing study protocol and patient related documents
Acting as insurance taker
Preparing and obtaining Regulatory Authorities/ Ethics Committee approvals and fulfill Sponsor’s Legal Obligations
Performing the study according to the Protocol and in compliance with local and international laws and regulations (e.g. ICH-GCP, registration in clinicaltrials.gov)
Monitoring and providing regular study progress to Servier as stated in the agreement.
Planning Servier product supply, labeling, and distribution throughout the study (if applicable)
Reporting all safety issues to appropriate Regulatory Authorities as per regulations and to Servier as per agreement
Independently (for ISS) publishing study results and forward a copy of study report as per agreement to Servier
Fulfilling regulatory requirements related to clinical trial data transparency

What can you expect from Servier?

Provide scientific medical review and comment on study concept/protocol
Provide agreement template including Safety obligations (if applicable) and Intellectual Property rights on the study results
Inform the Third-Party Sponsor on all safety obligations for the type of study as per Servier Standard Operating Procedure
Provide Third-Party Sponsor with needed information on the supplied Servier product, in particular safety information via provision of the Summary of Product Characteristics (SmPC) for registered products and/or the updated Investigator Brochure (IB) for products or indications under development
Provide product and/or funding as per agreement
Process safety events received from Third-Party Sponsor
Review any publication for medical accuracy and eventually final study report as per agreement
Perform medical safety review

Concept Submission & Review:

Servier is using the iEnvision platform from the submission of the study concept to study report/publication including study tracking progress.

You can choose the Therapeutic Area and consult Servier’s current research areas of interest per product directly on the platform.

Access the Servier ISS/CRS iEnvision platform

Documents / Information you need to submit in the platform:

CV as the principal investigator leading the research
Exhaustive Study Concept
Detailed Funding Request (if applicable)
Product supply needs (if applicable)

A confidentiality agreement will be signed by all parties.

The Study Concept will be reviewed internally by a Local Review 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 Study Concept is approved, a contractual Agreement will take place.

Conflicts of Interests – Transparency:

Servier follows a strict code of ethics which ensures compliance with regulations and ethical standards. Research proposals are assessed according to Servier’s current research areas of interest and strictly on their scientific merit and alignment with the Company´s overall research, global development strategy and 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.

The agreement (based on Servier template) will contain:

Final Protocol reviewed by the Servier Global Review Committee
Pharmacovigilance specifications in accordance with regulatory obligations and Servier requirements
Conditions of product supply, when applicable
Payment schedule based on agreed milestones, when applicable

We thank you for soliciting Servier for your research project.