Investigator Sponsored Studies

Welcome to Ipsen's Investigator Sponsored Studies (ISS) Portal

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.

If you would like to submit an ISS proposal, contact us via InvestigatorSponsoredStudies@ipsen.com

Requirements for Ipsen to support your study (ISS)

  • 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).

Who may apply ?

  • Health Care Professionals
  • Cooperative Groups
  • Research Institutions
  • Universities or Colleges

Requirements to get started

  • Your CV (detailing your qualification, experience in research, training on Good Practices)
  • Outline or Synopsis Form: study title, objectives, hypothesis, study design, study population (inclusion & exclusion criteria) and sample size, study treatment (if any), endpoints and timelines
  • Study Budget Estimate

Download the files

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