Submission Requirements

Submission Requirements

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 
    • Background/Rationale
    • Treatment
    • Indication
    • Hypothesis / Objective
    • Study design (randomized, blinded, multicenter, prospective, etc.)
    • Number of patients
    • Timelines
  • 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.