Regulatory Support Center

The Regulatory Core provides regulatory services to ICTS investigators that span the life of the study ranging from protocol and consent development, preparation and maintenance of FDA drug and device applications (IND/IDE), initial and ongoing submissions to the IRB, creation of case report forms, monitoring services for investigator-initiated studies, assistance and guidance with regulatory or institutional audits and study closeout processes. This group has extensive regulatory experience with these processes and collaborative working relationships with other institutional offices that oversee human research. This Regulatory Core staff will interact with the PI, FDA, sponsor (if not WU), reviewing committee(s), coordinators and other regulatory specialists, to optimally facilitate approvals.

Service available to All entities, including for-profit organizations.

Priority service for No distinctions.

• Pre-study consultation, IRB submissions, and other committees as required
• Prepare and negotiate budgets (including per patient) and payment terms with sponsors
• Perform Medicare Coverage analysis for clinical trials
• Protocol and consent development assistance for PI-initiated protocols
• Submission and maintenance of FDA IND or IDE applications
• Assistance with sponsor and regulatory audits of clinical trials
• Monitoring of investigator-initiated multi-center clinical trials

• no equipment

Please contact this core directly for pricing information.