FDA OSI Reports
AdClin help companies to report all the information requested by the FDA's Office of Scientific Investigation (OSI) by providing all the requested documents.
According to the FDA:
The goals of OSI are to:
- Verify the integrity of efficacy and safety data submitted to the FDA in support of new drug applications.
- Assure that the rights and welfare of human research subjects are protected.
OSI Accomplishes this by:
- Auditing and verifying clinical trial data submitted to the FDA in support of applications to demonstrate the safety and efficacy, or bioequivalence, of drugs for human use;
- Directing inspections of Institutional Review Boards (IRBs) for compliance with standards and regulations designed to protect the rights and welfare of human research subjects; and
- Ensuring that investigators, sponsors, and contract research organizations who conduct nonclinical and clinical studies on investigational new drugs comply with United States laws and regulations covering good clinical practice and good laboratory practice.
On a by site/by clinical trial basis, we provide all the listings requested by the OSI: subjects enrolled, discontinued, per protocol, etc. All the listings related to AEs, efficacy, concomitant medication, etc.
The deliverable are state of the art reports matching the OSI structure (Sections, annotated CFRs and Protocols).