investigator-initiated trials
Napo Pharmaceuticals’ Investigator-Initiated Trials (IIT) Program aims to advance our understanding of crofelemer by supporting high-quality research that is initiated and executed by external investigators.
what is the IIT program?
Napo Pharmaceuticals’ IIT Program is open to qualified researchers who are interested in conducting their own research. Each submitted Concept Proposal Form for an IIT will be evaluated by our IIT committee to ensure that the proposed research addresses an appropriate medical or scientific question that is aligned with the strategic goals of Napo Pharmaceuticals.
what are investigator responsibilities?
Clinical investigations must be conceived and executed by external investigators. All responsibility for the conduct of the study resides with the investigator and their institution, including ensuring that the study is conducted under the appropriate guidelines. Core requirements include:
- Submission of a scientifically well-designed and well-written proposal
- Scientific, technical, and operational capabilities to conduct a study as a sponsor, including staff who are adequately trained to execute a study (GCP, GMP, etc)
- Expert statistical support
- Adherence to timelines
- Ability to fulfill all regulatory requirements
- Delivery of a written report of the final study results to Napo Pharmaceuticals Medical Affairs
- Publication in a scientific journal
- Provision of periodic and as-required study updates to Napo Pharmaceuticals Medical Affairs
how are proposals submitted?
To be considered for review, the submitted concept proposal form must be completed in entirety. Click below to download this form.
