Standardize FDA Submissions | Maintain Compliance | Expedite Study Start-Up
The IND/IDE Regulatory Support Core is an efficient, comprehensive, and standardized resource that exists to aid OCTC investigators during all phases of their protocol life cycle. By reaching sponsor-investigators early in the FDA process, industry sponsors can benefit from the comprehensive services available through the Core, as well as receive consultative medical advice.
Tips For Success
- Knowledge is Power: Work with the IND/IDE Core to further understand the FDA process and the regulations that accompany new drugs, devices, and biologics
- Keep it Collaborative: The FDA is there to help investigators, so engage them in the planning process and utilize their knowledge!
- Explore Your Options: Contact the IND/IDE Core to understand the most efficient way to reach your goals
- Drive your Research Initiatives: Learn how to become an active sponsor-investigator through the IND/IDE Core Training Services
Protocol Review and Evaluation
Determination of most effective route with the FDA
Facilitate the creation and submission of a pre-IND or IDE
IND/IDE Application Assistance
Comprehensive support for the sponsor investigator through the application process with the FDA
Research Data Management Plan
Consultation and assistance on compliant data management and storage
Sponsor/Team Study-Start up Education
Intensive one-on-one training for sponsor-investigators and research personnel prior to study initiation
eRegulatory Binder and CRF Creation
FDA documents stored electronically and maintained in a validated part 11 compliant system.
Monitoring Plan and Evaluation
Monitoring tailored for specifically for investigator initiated protocol
Quality Control and Quality Assurance Evaluation
Evaluate and assist in establishing the QC and QA Plan for the study
Long-term Protocol Maintenance and Reporting Assistance
Long term protocol assistance available for the duration of the research trial
Visit the IND/IDE website: casemed.case.edu/ctsc/cores/ind-ide.cfm
Jenna Stump, FDA Regulatory Specialist (216)286-0754
Carolyn Apperson-Hansen, CTSC Research Concierge (216) 368-0035
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