Investigator Sponsored Studies

Ipsen supports independent research relating to disease areas of interest to Ipsen to advance research and enhance disease understanding. Investigator Sponsored Studies (ISS) investigators and/or their affiliated institutions take responsibility for the study as the Sponsor. The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. This means taking responsibility for all aspect of the study, including study:

• Design
• Regulatory approval
• Initiation
• Conduct
• Monitoring
• Reporting of safety data
• Analysis and publication of the results.

Your ISS proposal will be reviewed by Ipsen Medical Affairs Review Board for scientific merit as well as safety, legal, ethical and budgetary considerations. Support for endorsed proposals may be provided in the form of financial support and/or study drug supply pursuant to a written agreement which requires that you – as sponsor – comply with applicable local laws, rules, guidelines and regulations.

You are invited to submit your research proposal (outline) via VisionTracker, Ipsen’s ISS website. VisionTracker is an interactive system supporting the overall ISS workflow from outline submission up to project closure.

You will be invited to provide all relevant information directly via this website during the whole ISS lifecycle.

Access VisionTracker, Ipsen’s ISS website

• Click here to access Ipsen’s ISS website.
• If you are a Russian citizen, please contact Ipsen Russia by sending your VisionTracker access request to medical.information.russia.cis@ipsen.com Upon collection of your informed consent on personal data processing, your VisionTracker access will be granted.
• If you have difficulty with portal access, please email InvestigatorSponsoredStudies@ipsen.com for additional assistance.

Tutorials (instructional videos)

• • How to register on VisionTracker Ipsen’s ISS website:
    

• • How to submit a new ISS proposal:
    

• • How to submit a project status update and an amendment to active project:
    

For any questions related to the ISS process and/or submissions contact us via InvestigatorSponsoredStudies@ipsen.com

• You should have the appropriate scientific and operational capabilities and resources to conduct the study on agreed timelines.
• You should conduct the study in compliance with laws, rules, regulations and ethical standards (e.g. Declaration of Helsinki, Good Pharmacovigilance Practices, ICH-Good Clinical Practices, Good Pharmaco Epidemiology Practices, Good Laboratory Practices).
• A mutually agreeable ISS Support Agreement must be executed prior to study initiation.
• You should provide contractual agreed-upon study status updates.
• You should monitor and report safety data to the appropriate authorities, in a timely and accurate manner.
• In addition to reporting safety data to all relevant authorities, you have the responsibility to report the safety information to Ipsen in accordance with the ISS Agreement.
• You should complete a final study report and/or manuscript in all cases (study completed as per plan or study prematurely terminated).