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Clinical Investigator Initiated Studies (IIS)

Clinical Investigator Initiated Studies (IIS)

Investigator initiated studies (IIS) are clinical studies initiated and managed by non-pharmaceutical company researchers. The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations.

Type of support provided for IIS

Guerbet may support investigator initiated studies with, funding, material and/or information/supply, as allowed under applicable laws and regulations, if they align with the company defined areas of strategic interest. Link to priority topics on Guerbet corporate website

Eligibility requirements for clinical IIS

They will be evaluated according to the following criteria: medical and scientific significance (innovation level), expertise of the Investigator/sponsor in the field, experience of Sponsor & study team in study conducting, and study quality (including methodology, quality of design, feasibility…).

Types of studies eligible for support:

  • Interventional & Non-Interventional clinical studies
  • Retrospective analysis of patient’s data

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

  • Have the capabilities to conduct a study
  • Deliver publication within agreed timelines
  • Fulfill all regulatory requirements
  • Etc.

Each submission will follow a review workflow of max 60days as below:

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