Services Offered

CMSU offers a complete range of supply services for clinical trials. We can manage your supply needs from start to finish, or help with any of the more specific needs you may have.

How We Can Help

CMSU has carefully considered each step of the clinical trial supply process. In our work with researchers both here and across the country, we have tested and developed the very best methods for meeting your supply needs. Here is how we can help you at every stage of the supply process.

Clinical Supply Chain Strategy

  • Develop optimal drug packaging and supply strategies.
  • Help avoid delays and control costs.
  • Utilize extensive experience and knowledge in the regulated environment.
  • Handle issues associated with couriers and delivery challenges.

Clinical Supply Chain Project Management

  • Apply expertise in large, long-term and complex protocols.
  • Assess packaging, labeling and dosing instructions with patients, nurses, and physicians.
  • Monitor packaging, labeling, distribution, expiration/retest monitoring and return/destruction.

Clinical Drug Label Design, Printing and Application

  • Optimize material utilization, supply and re-supply strategies, expiry/retest dates and costs.
  • Provide our cGMP compliant labeling system:
    • Documented label production
    • Audit log
    • Print run batch records
    • Labels with unique codes
    • Strict label control and issuance

Primary and Secondary Investigational Drug Packaging Solutions

  • Design creative and effective packaging.
  • Meet product requirements and patient security standards.
  • Meet patient and investigator compliance standards.
  • Offer labeling and assembly options including:
    • Single and multi-lingual labeling
    • Booklet design and procurement
    • Open, double and unblinding cards
    • Manual labeling
    • Dedicated patient kit assembly
    • Inclusion of dosing instructions
  • Provide fully mocked-up kits, including all labeling options, prior to production and for presentation at investigator/orientation meetings.
  • Just in-time packaging.
  • Temperature-sensitive material preparation.

Study-Specific Randomization

  • Sample size/power calculation.
  • Randomization plan, including initial and re-supply shipment sizes to sites.
  • Collaboration with the Department of Biostatistics and Computational Biology at the University of Rochester to provide randomization services.
  • Creation of drug disclosure envelopes.

Storage Options

  • Room temperature and humidity controlled warehouse.
  • Automated environmental monitoring system.
  • Refrigerated storage from 2°C to 8°C.
  • Temperature monitoring upon request.

Secure Environment

  • External building security via swipe card only.
  • Visitor entrance allowed only with an escort.
  • 24/7 motion-sensitive security camera monitoring of external building and storage warehouse.
  • All room access via swipe card with 21 CFR Part 11 compliant logging of all activity 24/7.

International Trial Drug Distribution

  • Dedicated project managers with extensive experience in supply logistics for clinical trials.
  • Professional advice to help optimize the distribution strategy ensuring that it is fully integrated with the packaging and labeling process.
  • Fully integrated shipment tracking system.

Investigational Drug Returns Management

  • Determined at outset of the study to meet regulatory and environmental requirements.
  • Destruction performed in-house, at the clinical site, or by third party reverse distributor depending on client procedures and nature of the material.
  • Written approval by client prior to any destruction.
  • Complete documentation of amount destroyed and destruction method.

Trial Archiving

  • Archived in accordance with FDA and ICH requirements.
  • Long-term off-site storage provider: Iron Mountain.

The CMSU is licensed by the New York State Board of Pharmacy #028772.