By Deborah Borfitz
August 4, 2008 | The logistics of executing clinical trials on a global scale has emerged as a major challenge for study sponsors with limited infrastructure. That’s the impetus behind Parexel’s continued expansion of its clinical logistics capabilities, most recently into the Asia-Pacific and Latin American regions, says Jens Mattuschka, director of clinical logistics within the company’s clinical research services division.
“Clients, especially smaller companies, want to outsource their clinical logistics function and have turned to Parexel, since we can provide centralized coordination of their clinical study supplies, lab services, and ancillary supplies worldwide,” says Mattuschka. In order to meet trial deadlines and milestones, it is critical for sponsors to have access to a network of regional logistics experts “who understand import/export requirements and can develop – region by region and country by country – a strategy for a company’s clinical supply chain. We provide this expertise to clients.”
Expansion of clinical logistic services was driven in part by Parexel’s September 2007 acquisition of long-term alliance partner APEX International Clinical Research Company, “significantly” bolstering Parexel’s presence in 11 Asia-Pacific countries, says Mattuschka. In Latin America, Parexel has an established presence in “important clinical development centers” such as Argentina, Brazil, Chile, and Mexico.
One success factor in global trials is “integrating external vendors, such as analytical laboratories, into the study process,” says Mattuschka. “In this regard, our team of dedicated logistics experts, who are part of Parexel’s Clinical Research Services, support clients in all areas of GxP compliance, including GCP [Good Clinical Practice] and GLP [Good Laboratory Practice].”
Outsourcing clinical logistics to Parexel takes away two of the top challenges sponsors face when they orchestrate global trials independently, says Mattuschka. One is contracting with multiple vendors throughout various regions. The other is coming up with a distribution plan for Investigational Medicinal Products based on country-specific patient enrollment forecasts, which “requires early involvement of logistics experts for clarification of importation and regulatory demands.” Managing such challenges for clients leads to “benefits such as a shorter set-up time and improved compliance.”
Paraxel also has sophisticated technology to support various aspects of clinical logistics, including tracking shipments and inventory levels, through the IMPACT Clinical Trial Management System of its Perceptive Informatics subsidiary. The software allow for “data exchange, the management of logistics tasks such as shipment tracking and inventory supply as well as providing interfaces for sharing of information from external analytical laboratories with the clinical database,” says Mattuschka. “This helps to organize sourcing, storage, and transportation of study material, such as study-related documents and laboratory materials.”
Other key applications include a Laboratory Operations Management System (LOMAS) for lab results management customized to support Clinical Logistic Services, says Mattuschka. “LOMAS tracks samples against trial protocols and maintains a secure lab database.”
Integration of clinical logistic services with all other clinical research services ensures that the supply system “meshes seamlessly with study requirements and timelines,” says Mattuschka. “The importance of an effective clinical trial supply system cannot be underestimated. If it works effectively, sponsors can greatly reduce costly overproduction and overstocking of study drug, decrease the risk of expired inventory, and prevent supply shortfalls that jeopardize a trial.”
At 63 locations in 52 countries, Parexel now has an on-the-ground presence, says Mattuschka. It has extensive experience conducting studies in nearly 100 countries, covering the full spectrum of clinical development services.
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