• Study criteria
    • Your proposal must be entered into the online portal for review by the committee. Prior to entering your concept submission online, careful consideration should be given to the following sections:   

      • Proposal type (Investigator Initiated Trial versus Sponsored Research Agreement)
      • Study type (Clinical Interventional, Clinical Non-Interventional, versus Nonclinical)
      • Type of support (drug, funding, medical writing, data management, statistical analysis, etc.)
      • Projected study milestones/timeline (Total study duration, Final Data Availability, Planned Study Start, Planned Enrollment per month, etc.)

      An Investigator-Initiated Trial (IIT) is an unsolicited preclinical, clinical, outcomes- or disease-state-related study. An investigator independently generates a research proposal and Biogen may only provide support in the form of funding, study drug or access to Biogen data sets and banked lab samples.

      Sponsored Research Agreement (SRA) is a collaboration between Biogen and an investigator on a research proposal. Biogen and the investigator collaborate on the design and the interpretation of the results. Biogen may support the research beyond funding, study drug or access to Biogen data sets and banked lab samples. Publication and authorship will be based on ICMJE criteria.

      For both IITs and SRAs, the investigator, or his/her institution, remains as the study regulatory sponsor. The sponsor assumes responsibility for initiating and conducting the study, directing the administration of study drug (if applicable), and ensuring compliance with all local laws and regulatory requirements. 

  • Support requested
  • Review process
  • Contracting
  • Publications