Investigator Sponsored Studies (ISSs) and Externally Sponsored Collaborations (ESCs) are both clinical and nonclinical studies that are designed and managed by an investigator and sponsored by this investigator or the organization he works for. This individual assumes responsibility for the duration of their study, managing and conducting the research. We welcome well-written, scientifically sound studies to achieve a multitude of goals, such as improving patient care or sparking new ideas for disease-related research.

Support for an approved ISSs or ESCs may come in various forms, including funding, product and/or material, or in some cases, both funding and product, as allowed under local laws and regulations.

The following information and steps are required for study concept submission. Note that Sanofi Scientific Review Committee (SRC) approval is required for the Study Proposal (end of step 1). Also note that you will be requested to provide the Fair Market Value (FMV) budget and the final Protocol (i.e., steps 1 and 2).

Step 1: Study Proposal Submission

• Study Title
• Therapeutic Area
• Indication
• Primary Investigator Information
• Site Information
• Proposal
• Scientific Summary
• Requested Funding, if applicable, with a preliminary Budget FMV
• Requested Product, if applicable
• Other support requested, if applicable
• Planned Publication(s)

Step 2: Protocol Submission

• Protocol
• Protocol Budget FMV, if applicable

*Note that under certain circumstances, the proposal and protocol may be submitted concurrently

Step 3: Contracting

• Negotiations
• Final Budget FMV, if applicable
• IP (Drug Supply), if applicable
• Safety Language

Step 4: Post-Protocol Approval Project Requirements

• Ethics Approval
• Regulatory Information
• Clinical Trial Registration Information
• Informed Consent Template

Step 5: Study Progress Requirements

• Study Status Updates (occur periodically throughout study)
• Product Re-Supply
• Potential Amendments (if necessary)
  Requirements:
  • Clean copy of amended protocol
  • Tracked changes copy of protocol
  • Summary of changes document

Step 6: Study Finalization

• Final Study Report (FSR)
• Publications
  • All publications must be provided to Sanofi for review prior to submission to Journal/congress

To apply, please ensure that you, or the Primary Investigator of the research, meeting the following requirements:

• You are a physician, pharmacist, or researcher. You must be qualified by training and experience to undertake the proposed research, and the nature of the research must be appropriate to your background.
  • 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 proposal and protocol will be authored by you, except in some instances if the study is an Externally Sponsored Collaboration (ESC) with Sanofi.

You will be required to register, upload your current CV, license (US only), and global identification number (if applicable), and describe your research plan.

For ISS submissions, you may discuss with your local country contact once the proposal has been submitted in the iEnvision system. ESCs are considered collaborative in nature and discussions can occur outside of iEnvision.

There are two steps in the application process:

1. Submission of your study proposal and evaluation within Sanofi.
2. If there is an interest to support your study, you will be asked for the full protocol and detailed budget.

At each step, you may be required to provide additional information through the web portal. If the study is approved by Sanofi, you will be asked to agree on the contract, fulfill post approval requirements and provide study updates on a regular basis.

Sanofi endeavors to respond within one month from the time you submitted your application. More time may be needed for complex studies or during some holiday periods (e.g., Christmas time or summer vacation). Also, you may contact your country field representative if you have any questions.

Please reach your Sanofi contact who will ensure the system is reopened for your modifications of the proposal related fields. Please note that this will be possible at Proposal and Protocol steps.

Please contact Envision support team. Email: helpdesk@envisionpharmasupport.com