Investigator-initiated Studies

Sunovion provides support for investigator-initiated research that advances medical and scientific knowledge about Sunovion products and therapeutic areas of interest.

Sunovion enables research that has the potential to improve the treatment of disease, patient outcomes and the quality of health care through its investigator-initiated studies (IIS) program.

Academic and community-based scientists who are interested in conducting their own research are welcomed to apply.

Sunovion accepts concept submissions and if it is of interest, a request for a full submission will be made.

Submit a Research Concept

Concept submissions must include sufficient information for Sunovion to determine interest. At a minimum a concept proposal must include the following:

  • A letter of request including the principal investigator contact information
  • Proposed study title
  • Type of support: financial, drug or both
  • Sunovion drug and non-Sunovion drugs as part of study
  • Total funding requested (if applicable)
  • Brief study synopsis including rationale, objectives and study design

Full submissions must include the following (if applicable):

  • A letter of request including the principal investigator contact information
  • Proposed study title
  • Type of support: financial, drug or both
  • Total funding requested (full budget must be attached)
  • Sunovion drug and non-Sunovion drugs as part of study (formula, strength, quantity/commercial or pure substance)
  • Study synopsis and full protocol, including but not limited to:
    • Brief study rationale
    • Primary endpoints
    • Inclusion/exclusion criteria
    • Statistical methods
    • Target enrollment
    • Treatment plan and dosing
    • Study start and end dates as well as study duration
  • CV or bio for principal investigator/s
  • W-9
  • Informed consent

Sunovion will not provide funding for the following:

  • Requests for funding of research without an associated study protocol or synopsis
  • General education and training activities
  • Routine operations of an organization
  • Start-up funding to establish new programs
  • Purchasing of capital equipment unrelated to the study or that would generate income
  • Construction funds

Salaries of staff not dedicated to the study

Review Process

Sunovion will acknowledge receipt of all grant requests. The review process is conducted by Sunovion’s Scientific Review Committee and decisions are made based on medical and scientific merit as well as available budget. A formal notification on the status of your request will be sent by email once a decision is reached. All inquiries should be directed to grants@sunovion.com.

Should your request be approved, Sunovion requires copies of the following documents:

  • IRB approval
  • Regulatory responses (IND or CTA)
  • Fully executed IIS agreement
  • Final Protocol (please note: if final protocol is substantially different from that in your approved request or if the protocol is changed after the study is initiated, Sunovion reserves the right to reconsider its support. All material changes will need to be reviewed by the Scientific Review Committee.)

Ongoing Study Maintenance

Sunovion requires monthly enrollment updates, projected publication and study completion dates in order to stay on track with Sunovion’s financial requirements and projections of the contracted milestone payments. Grant recipient must record all relevant information on www.clinicaltrials.gov, if applicable. Please see above for information regarding protocol changes. When a study is completed, the investigator must provide Sunovion with a final study report and financial/drug supply reconciliation. Other forms may be requested as needed upon study closeout.

Safety Reporting Requirements

Sunovion requires that, within 24 hours of first awareness of the event (or immediately if the event is fatal or life-threatening), the principal investigator will report to Sunovion any Serious Adverse Event (SAE) that occurs in a study subject assigned to receive the Sunovion product. Such SAEs must be reported using an approved local regulatory form (i.e., MEDWATCH). SAEs should be reported even if complete information is not yet available. The reportable events that are subject to this requirement are those that occur from after the first dose of a Sunovion product through twenty-eight (28) days after discontinuation. The investigator will assist Sunovion in investigating any SAE and will provide any follow-up information as requested by Sunovion. Reporting an SAE to Sunovion does not relieve the investigator of the responsibility for reporting the SAE to the FDA or other applicable authority.

Financial Disclosure

The U.S. Physician Payment Sunshine Act requires all pharmaceutical, biologic and medical device manufacturers to report annually to the U.S. government payments and transfers of value made to U.S. physicians and teaching hospitals. This may include research grants. Sunovion will report the name of the organization to which the funding is provided and will list the name of the associated principal investigator/s.

Sunovion accepts concept submissions from academic and community-based scientists, and if it is of interest, a request for a full submission will be made.

Submit a Research Concept