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Investigator Sponsored Studies (ISS)

Content :

Investigator Sponsored Studies (ISS)

Our Mission

Sanofi-U.S., A SANOFI COMPANY 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 US. 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

Federal law requires that, as of January 2012, pharmaceutical companies collect information relating to payments and transfers of value to physicians and teaching hospitals, and submit this information to the government for publication on an internet site beginning in 2013. Several states already have similar requirements.

Summary of ISS Process

Summary of ISS Process

Sponsor-Investigator

Sanofi US

Application & Review

Step 1: Summary of Concept

  • Review of Summary of Concept
    Communication of decision to decline or request full detailed concept

Step 2: Concept

  • Fair Market Value review
  • Inform all applicants of decision
  • Inform approved applicants of next steps and provide information for protocol submission

Step 3: Full Protocol Submission

  • Inform applicant of grant decision
    Grant
Grant

Step 4: Requirements for Grant Activation

  • Review all submitted final documents
  • Negotiate, finalize, and execute contract

Step 5: Grant Activation

  • Issue initial grant payment
  • Issue first drug shipment
Study Conduct

Step 6: Research

  • Monitor progress and continue

Step 7: Data Reporting

  • Review submitted Final Study Report and/or a quality draft manuscript may be used as the final deliverable per study agreement.

Step 8: Final Grant Reconciliation

  • Notify Sponsor-Investigator if repayment is necessary

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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 Federal or State health care programs
    • You are not an employee of Sanofi US or its affiliated entities
  • The research idea is yours and the Concept/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 US or its affiliates

You will be required to register, upload your current CV, license, and National Provider Identifier (NPI) information (if applicable), identify an area of interest, and describe your research plan.


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Responsibilities of Sponsor-Investigator

  • Signing of Confidential Disclosure Agreement where applicable
  • Submission of an investigational new drug application (IND) letter by the FDA (or FDA exemption letter) if appropriate. Please note your trial may be exempt from this requirement. For information on IND requirements, please review 21 CFR Part 312 - Investigational New Drug Application.
  • Submission of final study report and manuscript, and posting on ClinicalTrials.gov, as applicable
    • Provide National Clinical Trial (NCT) number relating to ClinicalTrials.gov listing
  • 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 US or its affiliates

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Contacts & Links

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

Or call Sanofi US Hotline: 1 866 841 4549, Option 2


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

https://sanofi.envisionpharma.com/vt_genzyme_sanofi/


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

https://genzyme.envisionpharma.com/vt_genzyme_sanofi/


To access the Regeneron ISS portal for submission of proposals for the investigational agents alirocumab, dupilumab and sarilumab, click on this link:

https://iisgrants.regeneron.com



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US.COR.14.10.008


Last update: January 19, 2015