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URMC / Clinical Materials Services Unit / Clinical Trial Services
 

Clinical Trial Services

Clinical Trial Packaging and Labeling Services

Clinical packaging services include kit design and label creation and production are fully compliant with the cGMP regulations. CMSU utilizes its validated, 21 CFR Part 11 compliant labelling system (ClinPro LBL ™) for the production of clinical labels and expert users to produce the labels in accordance with the Clinical Protocol and Federal Regulations. Packaging and labelling operations are driven by customized Standard Operating Procedures. Clinical materials are QA inspected upon receipt at the CMSU, throughout processing (labeling and kitting) and at completion of the processing order. All movement of materials is overseen by the dedicated Quality Assurance Unit.

Storage: Controlled Room Temperature and 2ᵒ – 8ᵒ C

Validated HVAC systems and refrigerators are backed up by emergency gas-powered generators. A dedicated monitoring system alerts CMSU staff in the case of deviation or temperature excursion.

Cold Chain Shipping

CMSU utilizes validated, cold chain pack-outs which monitor the in-transit temperature of the clinical materials through to its ultimate destination. The data-logger reports are retrieved from sites, QA reviewed and filed in the regulatory files. Any deviations in temperature outside acceptable limits are reported to the study sponsor for investigation and resolution.

Supply Chain Management

We will utilize our in-house expertise to assure that the entire supply chain of primary and secondary components, clinical labels, investigational drug distribution and device supply, and concomitant medications are delivered on-time and at low cost.

Drug Supply Sourcing

CMSU works with other supply-side vendors and wholesale distributors to ensure the highest quality lowest cost materials are sourced, managed / handled in compliance with Federal and State regulations and in compliance with all project requirements.

Returns Handling

Return and Disposition of used and unused materials must be carefully coordinated with Sites and Sponsors to assure adequate accountability of supply status. CMSU possesses many years of experience in handling of returns in a regulatory compliant manner from the perspective of both FDA and EPA.

Destruction of Used and Un-Used Supplies

Once full accountability of the investigational articles is established CMSU will petition the Sponsor to approve its final disposition and ultimate destruction in a regulatory compliant manner.

Regulatory and Support Services

CMSU can provide regulatory support services for IND’s, CTA’s and IMPD’s as necessary to complete your applications. CMSU has provided input and technical writing support for hundreds of IND’s and numerous CTA’s and IMPD’s.