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 Biotek, 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:
[email protected]

By mail, please send to:
233 Mt. Airy Road, Suite 100
Basking Ridge, NJ 07920