Clinical Study Request
Clinical Investigator Initiated Study Support Requests
The Investigator Initiated Studies Committee is charged with considering requests for clinical study support.
For clinical studies, the investigator is responsible for obtaining IRB approval prior to Allgens Medical, Inc. providing initial funds for the study. 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:
- The name and address for the institution
- A study protocol
- CVs of the investigators
- The amount requested and a budget of how the funds would be spent
- The anticipated timeline of the study
Additional information may be requested.
Where to submit a study request
Via e-mail, please send to:
By mail, please send to:
233 Mt. Airy Road, Suite 100
Basking Ridge, NJ 07920