• 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 – In the online portal, you will be prompted to indicate which type of proposal you are submitting to Biogen.  Ensure you select the appropriate type based upon the definitions below.

      Investigator-Initiated Trial (IIT) is a pre-clinical, clinical, outcomes- or disease-state-related research proposal not solicited by Biogen. The investigator independently generates a research proposal and Biogen only provides 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 (see “type of support” listed below). Publication and authorship will be based on ICMJE criteria. Please contact a Biogen Medical Director (MedicalResearch@biogen.com) for guidance on project planning and submission.

      The investigator is the study regulatory sponsor or accountable party for both IITs and SRAs. This means that the investigator 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.

      • Study type – In the online portal, you will be prompted to indicate the type of research proposal you are submitting to Biogen.  Select the most appropriate study type based upon the definitions below.   

      A Clinical Interventional study is a research project involving human participants undergoing treatments, assessments, or other practices that are not defined as standard of care by local Regulations.

      A Clinical Non-Interventional study is a research project involving human participants in which all treatments, assessments, and other practices are defined as standard of care by local Regulations.

      A Nonclinical Study is a research project that does not include human subjects, e.g, animal studies, ex vivo studies, in vitro studies, previously biobanked / stored clinical samples when prior informed consent permits their use for the intended research.

      A Data Analysis project is a research project evaluating existing data.

      • Type of support. With adequate justification, we are able to provide the following support:
        • Drug: Commercial or research drug can be provided depending on request.
        • Study funding: This includes direct costs, i.e. procedural and personnel, as well as indirect costs (e.g. overhead), publications, IRB review, CRO / vendor fees, etc.
        • Data and sample access: Access to Biogen datasets, biobanked samples, or stored images.
        • Medical writing: Assistance with writing of manuscript, posters, and the like by Biogen personnel or by contracting and managing vendors.
        • Data management: Assistance with data storage, review, handling, and cleaning.
        • Statistical analysis: Assistance with development of the sample size justification calculation and / or the statistical analysis plan.
        • Project / vendor management: Assist with selecting, contracting, and managing vendors required to complete your project.
      • Projected study milestones/timeline. We will need specific information on the total study duration, planned study start, planned milestones (e.g. enrollment per month), and plans for presentation or publication of study results.

  • Support requested
  • Review process
  • Contracting
  • Study conduct
  • Publications