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.
The funding of your research does not impose an obligation, expressed or implied, on the recipient to purchase, prescribe, provide favorable formulary status for, or otherwise support Ipsen products.
How to apply for ISS support?
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.
- For any questions related to the ISS process and/or submissions contact us via InvestigatorSponsoredStudies@ipsen.com
- 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.
How to register on VisionTracker
How to submit a NEW ISS proposal
How to submit an Update / Change
Who may apply ?
- Health Care Professionals
- Cooperative Groups
- Research Institutions
- Universities or Colleges
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).
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, timelines
- Study Budget Estimate
- You submit a new ISS request via VisionTracker.
- Ipsen will perform a quality and completeness review.
Estimated timelines: We will aim to confirm our interest within 4 weeks.
- You submit a detailed synopsis via VisionTracker.
- Ipsen Review Board perform review and assessment.
Estimated timelines: We will aim to communicate the outcome from the assessment within 8 weeks.
- 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 study close-out.
Publishing your ISS
Researchers have an ethical duty to publish the clinical research they do. Publishing your scientific research can benefit patients and society as a whole – as well as the wider research community.