IIR PORTAL

ELIGIBILITY

Dompé may support Investigator Initiated Research (IIR) with drug supply, funding, material and/or information, as allowed under local laws and regulations, provided that they align with Dompé defined areas of strategic interest.

Types of IIR eligible for support:

  • Clinical studies of DompĂ© Therapeutics marketed drugs for approved or investigational uses

  • Clinical studies of DompĂ© Therapeutics investigational drug product (interventional, non-clinical, phase I to IV)

  • Observational studies of real-world experience (retrospective, prospective, EHR, database or epidemiology, patient reported experience, HEOR) in areas of interest

  • Non-clinical studies (animal or laboratory)

  • Registries

  • Literature Reviews or Meta-Analysis

The following is out of scope:

  • Requests for compassionate use

 The sponsor/investigator has to fulfil (or agree to) the following requirements:

  • have the scientific, technical and operational capabilities to conduct research as a sponsor including adequately trained staff to execute a research study (GCP, GMP, etc.)
  • have expert statistical support
  • submit a scientifically well designed and well-written research proposal with well-defined research question (primary as well as secondary endpoints)
  • deliver to agreed timelines
  • be able to fulfill all regulatory requirements (including submitting a IND/CTA, writing of final research report and manuscripts etc.)
  • deliver a written report of the final research results to Dompé
  • register the research on external website (e.g. clinicaltrials.gov)
  • agree to safety reporting to health authorities and to Dompé
  • agree to provide research updates to Dompé