IPSEN´S INVESTIGATOR SPONSORED STUDIES (ISS) AND EXTERNALLY SPONSORED COLLABORATION (ESC) PORTAL
We are ready to consider unsolicited proposals from healthcare professionals (HCPs), scientists, and researchers or institutions (i.e. external sponsor) for research support based on scientific merit and strategic fit with Ipsen’s areas of research interest.
Requests for support will be assessed 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.
There are two types of unsolicited proposals: Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC):
- Investigator Sponsored Studies (ISS) are defined as independent unsolicited research, designed and sponsored by an external sponsor entity, institution or organization.
- Externally Sponsored Collaborations (ESC) are conducted in collaboration with an institution or organization based on a jointly defined research where primary regulatory sponsorship is held externally to Ipsen.
To be noted
- An Investigator Sponsored Study (ISS) may become a study under a collaborative model (ESC) during the discussion/evaluation of the ISS proposal from the external sponsor.
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.
You are invited to submit your research proposal (concept) via VisionTracker platform, an interactive system supporting the end-to-end workflow from concept submission up to project closure.
You will be invited to provide all relevant information directly online during the entire research lifecycle.
- Concept: Short description of the research/study. If in scope, the concept will move to synopsis requested stage.
- Synopsis: More detailed description of the proposed research/study.
- Protocol: Provide all study details.
- Project Set-up: Contracting, ethics review/regulatory approvals, budgeting, product shipment.
- Active Project: Research/study executed as per protocol and contract.
- Project closure: Final study report and publications, final reconciliations
Access VisionTracker
- Click here to access Ipsen’s ISS and ESC portal
- If you are a Russian citizen, please contact Ipsen Russia by sending your VisionTracker access request to 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.
For any questions related to the process and/or submissions, contact us via InvestigatorSponsoredStudies@ipsen.com
- Concept: study title, hypothesis, objectives, endpoints, sample size, support requested.
- You shall have the appropriate scientific and operational capabilities and resources to conduct the study on agreed timelines.
- You shall 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 contract must be executed prior to study initiation.
- You shall provide contractual agreed-upon study status updates.
- You shall 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 as per contract.
- You shall complete a final study report and/or manuscript in all cases (study completed as per plan or study prematurely terminated).
- 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.