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Clinical Services

Protecting the Integrity of Your Clinical Study Cold Chain
Over $260 billion of annual biopharma sales are dependent on cold chain logistics to ensure product efficacy, according to the Department of Commerce, and they further state that logistics spending is currently more than $10 billion and is expected to grow to $13 billion by 2019 within this industry. With billions of dollars at stake, maintaining temperature controls across the entire supply chain for clinical trial materials from point of manufacture, through packaging, labeling, storage, and distribution to investigator sites is a primary objective and plays a critical role in bringing new drugs to market. Any weakness in the chain can compromise integrity, delay shipments, result in large financial losses, and raise the costs of clinical trials. 

Working with a clinical supplies partner that understands the industry and has the experience to guide its customers through the process is critical in ensuring cold chain reliability. Bellwyck Pharma Services has nearly a quarter century of clinical trial experience behind its name. The company has significant expertise in the field of cold chain logistics and, depending on specific product requirements, can offer various solutions. Bellwyck offers controlled room temperature, refrigerated (2° C to 8° C), and frozen(-20° C and -70° C) cGMP compliant storage solutions for clinical trial materials.

Controlling storage and transport conditions is critical. There are situations that require the product be outside of the refrigerator or freezer for short periods of time, such as for packaging and labeling based on product stability. Manufacturers or trial sponsors will communicate excursion limits to account for this. Bellwyck understands that temperature excursions outside the specified range can have a substantial negative impact on a clinical trial study, impacting the quality, efficacy and safety of products. Therefore, times in and out of storage are closely monitored and documented. For highly sensitive materials, those with low excursion times, and those with limited stability data, Bellwyck can provide cold processing and packaging.

Bellwyck also ships product to depots or investigators following manufacturer’s requirements to avoid exceeding excursion limits. There are no cookie cutter solutions, and Bellwyck works closely with each manufacturer or clinical trial sponsor to provide an optimal solution, while taking into account environmental conditions, seasonal changes, and geographic locations that can impact the shipping container’s ability to maintain the required temperature range. 
Bellwyck has facilities in the U.S. and Canada, which gives them the ability to perform these labeling, storage and distribution services in the country in closer proximity to the bulk manufacture location or the clinical trial sites By having locations in both U.S. and Canada they can ship domestically overnight directly to investigators without border crossings and customs clearance.