Social network
  • Visit We R Hope page

    We R Hope by Sanofi

  • Fighting dengue ferver

    Fighting dengue ferver

  • Meet Anne-Olivier Bandini: R&D Team Leader, France

  • Isabelle, Type 1 diabetes, France

    Isabelle, Type 1 diabetes, France

     

    Investigator Sponsored Studies (ISS)

    Investigator Sponsored Studies (ISS) include unsolicited research originating from an external researcher, institution, or organization and inclusive of 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.

    Sanofi is using the Vision Tracker system, open for use to investigators, for handling ISSs from the investigator initial request up to ISS report and publication, to provide more transparency on interactions between investigators and Sanofi. Note that this portal is not to be used for Grants, Donations, Charitable Contributions or collaborative study requests. Investigators can register/ log into the Vision Tracker system to view sanofi’s current areas of interest.

     

    Our Mission

    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. The company receives, reviews, and responds to unsolicited proposals from health care professionals (HCPs), scientists, and researchers or their institutions for research support.

     

    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
     

    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.

     

    Summary of ISS Process

    Summary of ISS Process
    Sponsor-InvestigatorSanofi
    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
    Study Execution
    and Reporting
    Step 4: Study Conduct
    • Review all submitted final documents and finalize budget
    • Approve final budget and payment milestones
    • Negotiate, finalize, and execute contract
    • Issue first drug shipment
    • 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 ineligible 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
    • You are not seeking funding for research that would otherwise be undertaken/paid for by your home institution or that is primarily for the institution’s benefit
    • You have the ability to grant an option to license inventions arising from the research to Sanofi or its affiliates

    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.

     

    Responsibilities of Sponsor-Investigator

    • Signing of Confidential Disclosure Agreement where applicable
    • Submission of application for study conduct to HA and EC according to local regulatory requirements.
    • Ensure data integrity
    • Ensure safety reporting to Sanofi and IRB/IEC/HA
    • Submission of final study report and manuscript to sanofi as per research support agreement and, as applicable, to local IRB/IEC/HA and/or posting on ClinicalTrials.gov
     

    Links & Contacts

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

    For proposals for ISSs 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:

    Questions can be sent to the email address: USISTManagementSys@sanofi.com

     

    Right area: