Pre-clinical and Clinical Investigator Initiated Study Support Request Procedure
The Investigator Initiated Studies Committee is charged with considering requests for pre-clinical and clinical study support. The committee may award funding to institutions, medical foundations, and professional societies whose mission includes public health treatment, scientific research and/or medical education.
For clinical studies the investigator is responsible for obtaining IRB approval prior to Bioventus providing the initial funds for the study. For pre-clinical studies, the investigator is responsible for following relevant national ethical guidelines. Both clinical and pre-clinical studies undergo an additional ethical review by the investigator initiated studies committee.
For new indication studies the investigator is responsible for obtaining regulatory approval through the appropriate national body. In the USA approval for investigator initiated IDE trials is provided by the FDA.
How to Request Support for a Study
Each written request must include:
1. The name and address for the institution
2. A study protocol
3. CVs for the study investigators
4. The amount requested and a budget of how the funds would be spent
5. The anticipated timing of the study
6. For product donations, a list of desired products should be provided
Additional information may be requested.
Areas of interest
- Low intensity pulsed ultrasound for bone and soft tissue healing
- Hyaluronic acid treatment for early osteoarthritis
- Bone healing biology
- Cartilage healing biology
- Orthopaedic soft tissue healing
Spine and Trauma Bone Grafting
Where to submit a study request
Via e-mail, please send to:
By mail, please send to:
Professional Affairs Department
Attn: Investigator Initiated Studies Bioventus LLC
4721 Emperor Blvd., Suite 100
Durham, NC 27703