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URMC / Center for Health + Technology / Our Expertise / Clinical Materials Services Unit

 

Clinical Materials Services Unit (CMSU)

Woman labeling plastic containers

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 56 drug and device multi-center clinical trials, and drug/device supplies to over 14,500 participants at more than 1,100 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