Investigator Sponsored Studies

How to Apply

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 through project closure. You will provide all relevant information directly via this website during the entire ISS lifecycle.

To begin, you will need:

  • 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

Access VisionTracker, Ipsen’s ISS website

If you have difficulty accessing VisionTracker, please email InvestigatorSponsoredStudies@ipsen.com for additional assistance.

 

How to Apply

Requirements

Who can apply:

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

For Ipsen to support your study:

  • You must have the appropriate scientific and operational capabilities and resources to conduct the study on agreed timelines
  • You must 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)

Requirements

Our ISS Process

Step 1: ISS Submission

  • You submit a new ISS request via VisionTracker
  • Ipsen will perform a quality and completeness review
  • Estimated Timeline: 4 weeks
Step 2: ISS Review

  • You submit a detailed synopsis via VisionTracker
  • Ipsen Medical Affairs Review Board (MARB) performs review and assessment
  • Estimated Timeline: We will aim to communicate the outcome from the assessment within 8 weeks
Step 3: ISS Execution

  • ISS support agreement is signed by all parties
  • You submit the final study protocol and the regulatory information via VisionTracker
  • You start the study activities
  • You provide regular Project Status Updates via VisionTracker
  • You must report safety findings to Ipsen (adverse.events@ipsen.com)
  • You submit the Final Study Report and/or Manuscript via VisionTracker
  • A final reconciliation is done via VisionTracker prior to the study close-out

Publishing your ISS

Researchers have an ethical duty to publish their clinical research. Publishing scientific research can benefit patients and society as a whole – as well as the wider research community.

Publishing your ISS

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