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 

Visit CMSU’s website