Investigators are encouraged to submit a well-written proposal supported by pre-clinical or clinical data with strong scientific rationale and an appropriate review of the literature. Investigators should demonstrate that they are able to:
- Conduct the study with the appropriate scientific, technical and operational capabilities
- Submit an IND/CTA, if necessary
- Meet agreed-upon timelines
- Write a final report or manuscript
- Provide contractual agreed-upon study status updates
- Have expert statistical support available for data analysis
The Primary Investigator should submit an ISS study proposal. Alternatively, an investigator may choose to submit a study synopsis, which is a brief summary of the study idea. A study synopsis should consist of the following:
- Brief outline of study
- Hypothesis / Objective
- Study design (randomized, blinded, multicenter, prospective, etc.)
- Number of patients
- Type and scope of support requested.
Once a proposal is reviewed and approved, the investigator will be invited to submit a full protocol for review. Please note, approval of a concept or proposal does not imply or guarantee approval of a full protocol.
Please contact your local Sobi medical representative to discuss your proposal and to receive a copy of the Sobi ISS application template. If you are not aware of who to contact please send an email for information.