Clinical Materials Services Unit (CMSU)
Clinical Materials Services Unit (CMSU)
The Clinical Materials Service Unit offers comprehensive clinical trial supply services including:
- Secondary packaging and labeling of clinical trial materials (drugs and devices)
- Distribution services/strategies (including cold chain)
- Package development, integrity and performance testing
- Label design and printing (21 CFR part 11 compliant)
- Storage options (room temperature and 2-8ºC)
- Clinical supply chain strategy and management
- Secure environment
- Returns management/destruction
The staff of CMSU have over 150 years of collective pharmaceutical experience and have serviced 15-20 multi-center studies concurrently, with average study size of 200 participants, 25 sites and up to 5 years in duration. CMSU has provided regulatory support for 14 investigator initiated INDs, services to 90 drug and device multi-center clinical trials, and drug/device supplies to over 25,000 participants at more than 2,100 sites.
CMSU also provides project management support:
- Kit design to align with dispensing visits
- Creation of drug accountability logs and operations manual
- Selection/auditing GMP-compliant contract manufacturing organizations
- Management of expiration dates