Investigator Initiated Studies
Investigator Initiated Studies
Optimer's mission, in supporting investigator initiated research, is to advance the delivery of quality healthcare through original research that will enhance the understanding of diseases and their treatment.
Submitting an Investigator Initiated Study (IIS) Request
Optimer® accepts concept submissions and full protocol submissions for Investigator Initiated Study grant requests. If a concept submission is of interest, a follow up request for a full protocol submission will be issued. A full protocol submission must be received in order for a request to be considered for approval. Request for submission of a full protocol does not signal Optimer’s conditional approval of the study. In order to submit an IIS, please click on the button located on this webpage.
Types of Research Eligible for Support:
- Clinical studies of approved and unapproved uses of Optimer drugs
- Observational studies, such as epidemiology studies, and certain outcomes research studies
- Independent research on disease states
- In vitro or preclinical studies
Optimer support typically is provided as funding and/or drug depending upon the type of research.
Review Process
Optimer will acknowledge receipt of all IIS submissions. The review process is conducted by an Optimer IIS Review Committee and decisions are made based upon medical and scientific merit, as well as available resources and research priorities. Consideration criteria include whether the proposed study is novel, innovative and/or verifies existing data and contributes to the scientific community. A formal notification on the status of your application will be sent once a decision is reached.
Questions
If you have questions on your research ideas or the submission process, please contact the Optimer IIS Management team at IISreview@optimerpharma.com
Your IIS Submissions
Set up your account, create your profile and view the status of your submissions.