INVESTIGATOR INITIATED TRIALS
The mission of the Napo Pharmaceuticals’ Investigator Initiated Trial (IIT) Program is to advance our understanding of crofelemer by supporting high-quality research that is initiated and executed by external investigators.
About the IIT Program
The Napo Pharmaceuticals’ IIT Program is open to qualified researchers who are interested in conducting their own research. Proposed research must address an appropriate medical or scientific question.
Applications to the program are reviewed by a committee of Napo Pharmaceuticals’ medical, scientific, regulatory, legal and operations staff based on their clinical value, scientific validity and rigor of the proposed research, benefits and risks to human subjects, confirmation that the study design meets ethical guidelines concerning human subjects in research, intellectual property considerations, amount of drug requested, experience of the investigator and research site, and alignment with Napo Pharmaceuticals’ values and clinical and or published areas of interest.
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 ethical, legal, and regulatory guidelines including ICH/GCP Guidelines. Product support is contingent upon full execution by both parties of an IIT research agreement.
Core responsibility requirements include:
- Scientific, technical and operational capabilities to conduct a study as a sponsor including adequately trained staff to execute a study (GCP, GMP, etc.)
- Expert statistical support
- Submission of a scientifically well designed and well-written study proposal
- Adherence to agreed timelines
- Ability to fulfill all regulatory requirements (including submitting an IND/CTA, writing of final study report and manuscripts, etc.)
- Delivery of a written report of the final study results to Napo Pharmaceuticals Medical Affairs
- Publish the study in a scientific journal (Napo review prior to publishing)
- Prompt safety reporting to health/regulatory authorities and to Napo Pharmaceuticals Medical Affairs
- Provide periodical and as-required study updates to Napo Pharmaceuticals Medical Affairs
All IIT submissions must be submitted by the applicant via this website. To be considered for review, applicants must complete the Concept Proposal Form in its entirety including an estimate of how much product will be needed to perform the study.
Submission of an IIT proposal does not ensure approval. All proposals are carefully reviewed and decisions are based on criteria mentioned above. Applicant will be notified of approval or denial of an IIT submission decision within 10 business days of IIT Committee meetings, which are held on a monthly basis.
To initiate the submission process, please click to download the Napo Pharmaceuticals Concept Proposal Form.
To submit a completed Concept Proposal, please use the upload form below. For more information on the IIT Submission and Review Process, please click to download the Napo Pharmaceuticals Instructions for Submission of Investigator Initiated Trial and General Guidance.
Submit Concept Proposal Form
Please submit inquiries to IIT@napopharma.com.