At Erlanger Institute of Clinical Research we work to facilitate the submission, approval, and maintenance of the clinical trials conducted within Erlanger Health Systems.
If you are interested in initiating a clinical research study with Erlanger, please contact us directly or submit an inquiry on our website. We offer the following services to our investigators:
- Trial search
- Feasibility surveys
- Agreement (CDA, NDA, MTA, CTA) process & management
- Site budget analysis & budget negotiations
- IRB initial submission (local and central)
- Regulatory submission
- Billing documents (MCA, billing grid / research orders)
- Training teams
- Database search / Prescreen
- Participant Enrollment
- Coordination of care & study activities
- Data management / CRF completion
- Lab collection & processing
- Regulatory & IRB submissions
- Dispense medications
- Drug / Device Accountability
- Patient Education
- Facilitate Monitors
- Continuous Training
- Safety Reporting
- Invoice for services
- Process study charges
- Review and ensure documents are current, complete, accurate and filed appropriately.
- Resolve any pending monitor findings/queries.
- Submit study closure with IRB.
- Final report to regulatory authorities.
- Review and ensure all records are current, complete, accurate and filed appropriately.
- Ensure notes-to-file exist for any deviations/occurrences that require additional explanation.
- Complete inventory assessment.
- Reconcile any product/supply discrepancies.
- Return/destroy product/supplies according to sponsor/CRO instructions.
- Maintain all required documentation of event.