Services
In compliance with University Policies, Georgia Pharmacy Law and requirements of study Sponsors and the FDA, the services offered by IDS cover all aspects of research drug management.
- Ensure adherence to regulations that govern management of investigational drugs
- Document process and protocol-specific training of IDS staff
- Maintain and archive pharmacy records in Vestigo for inspection
- Provide access to IDS records and study drugs for routine monitor review
- Prepare for and permit inspections from sponsors, auditors and FDA
- Provide assistance in protocol development for investigator-initiated studies
- Assist in study drug orderset development for Winship trials
- Create drug ordersets for all non-Winship studies
- Set up all studies in Vestigo for protocol management
- Provide final study records to sponsors at study closeout
- Process prescription orders for investigational drug doses
- Prepare and label research drug doses
- Receive and document patient returns for oral drug studies
- Maintain Access to Sponsor-provided IXRS Systems
- Maintain randomization and blinding processes for double-blind studies
- Compound IV doses in accordance with USP797 and USP800 regulations
- Handle and dispense hazardous research drugs according to USP800 regulations
- Compound capsules for investigator initiated studies, in accordance with USP795 regulations
- Receive and maintain protocol-specific inventory for all clinical trials
- Conduct cycle counts
- Monitor drug expiration dates
- Process drugs for destruction or return to sponsor
- Store drugs according to manufacturers’ requirements
- Monitor temperature in all drug storage areas and provide data to sponsors
- Provide Central Coordinating drug distribution services for certain multicenter, institutional protocols
Rates
IDS rates are designed to cover all operating costs. At the beginning of each fiscal year, we review IDS Rates and make adjustments, as needed. Click here to see our rates.