Investigator Sponsored Studies and Externally Sponsored Collaboration



Sanofi is committed to supporting medically and scientifically sound research aimed at the advancement of disease knowledge and potential treatments in therapeutic areas of interest to Sanofi with the goal of advancing patient care. Sanofi receives, reviews, and responds to unsolicited proposals from health care professionals (HCPs), scientists, and researchers or institutions (i.e. external sponsor) for research support.

There are two types of unsolicited proposals: Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC):

Investigator Sponsored Studies are defined as unsolicited research originating from an external sponsor entity, institution or organization and include studies also known as investigator sponsored trials (IST), expert initiated research (EIR) or any other term which may reference investigator-sponsored or investigator-initiated research.

Externally Sponsored Collaborations are conducted in collaboration with an institution or organization (the external sponsor must not be a pharmaceutical company nor a vendor. Individual investigators are not eligible to enter into an ESC with Sanofi) based on a jointly defined research where primary regulatory sponsorship is held externally to Sanofi. 

To be noted:

  1. Sanofi is using the Visiontracker system, open for use to external sponsors for handling externally sponsored research from the initial request to the final study report and publication, to provide more transparency on interactions between external sponsors and Sanofi. External Sponsors can register/log on to the Visiontracker system to view Sanofi's current areas of interest. Please note that this portal is not to be used to request donations or other charitable contributions.
  2. An ESC might be solicited by Sanofi or by an external institution/organization to be developed jointly. Hence, the Visiontracker system might also collect ESC from an institution/organization.
  3. An Investigator Sponsored Study (ISS) may become a study under a collaborative model (ESC) during the discussion/evaluation of the ISS proposal from the external sponsor.

Types of eligible research

  • Preclinical and clinical studies
  • Observational studies, e.g. epidemiological studies or outcomes studies
  • Other research, e.g. disease states, diagnostics, medical devices, screening tools, and surveys

Process

EXTERNAL SPONSOR SANOFI
Application & Review Step 1: Summary of Concept Submission in Visiontracker
  • Review of summary of concept
  • Communication of decision to decline or request study outline
Step 2: Study Outline Submission in Visiontracker
  • Review of study outline
  • Initiate fair market value review
  • Communication of decision to decline or request protocol
Step 3: Full Protocol Submission in Visiontracker
  • Review of protocol
  • Communication of decision to decline or initiate research agreement activities
Negotiate, finalize, and execute contract
Study Execution and Reporting Step 4: Study Conduct
  • Review all submitted final documents and finalize budget
  • Approve final budget and payment milestones
  • Issue first drug shipment (when applicable)
  • Monitor progress
Step 5: Results Reporting
  • Review submitted final study report and a high-quality draft manuscript

 

Applicant requirements/responsibilities

In order to apply, please ensure you meet the following requirements:

  • You are a physician, pharmacist, or researcher, as appropriate to the nature of the research for which support is sought, qualified by training and experience to undertake the proposed research:
    • If conducting clinical research or research that involves patients, your license is current and may be verified
    • You are not excluded, debarred, suspended, or otherwise not eligible to participate in health care programs in your country
    • You are not an employee of Sanofi or its affiliated entities.
  • The research idea is yours and the study outline/protocol will be authored by you, except if the study is an Externally Sponsored Collaboration with Sanofi.

You will be required to register, upload your current CV, license, and global identification number (if applicable), identify an area of interest, and describe your research plan.

Important note on disclosure

Sanofi is committed to transparency in its interactions with healthcare professionals and health care organizations/institutions. Consistent with applicable laws and/or codes of practice applicable to the pharmaceutical industry, certain information related to the project [including but not limited to, the names of the Parties, the amount of funding (including fees and expenses reimbursed) as well as the title and purpose of the agreement may be communicated to any relevant authorities/institutions and/or publically disclosed by Sanofi and/or by its affiliated companies and/or by relevant authorities /institutions].

Responsibilities of the External Sponsor

  • Signing of confidential disclosure agreement where applicable
  • Submission of application for study conduct to health authorities and ethics committee according to local regulatory requirements
  • Ensure data integrity
  • Ensure safety reporting to Sanofi and institutional review board/independent ethics committee/health authorities
  • Submission of final study report and manuscript to Sanofi as per research support agreement and, as applicable, to local institutional review board/independent ethics committee/health authorities and/or posting on ClinicalTrials.gov

Links

To access the Sanofi ISS/ESC Visiontracker Registration/Login page click on this link:

For proposals for ISS/ESC to be conducted in the US for the investigational agents alirocumab, dupilumab and sarilumab, requests should be submitted to Regeneron. To access the Regeneron ISS portal, click on this link: