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Mar 15, 2009 (Vol. 29, No. 6)

Maximizing Value in Outsourcing Services

Guidance on How to Do More with Less while Maintaining High Levels of Quality

  • Trials in China

    Performing clinical trials in China also has both advantages and disadvantages, according to Patrice Hugo, Ph.D., vp, scientific affairs, MDS Pharma Services.

    “The differences in Chinese trials and in global programs that include China are not unique to a geography or therapeutic specialty. As with any country, there are processes, regulations, and culturally specific issues that affect the timeline and resources needed to conduct a trial.

    “Issues that affect a trial’s timeline include the acquisition of a clinical trial permit. Unfortunately, this process could delay study start time significantly, up to a year from initiation. Additionally, there are regulatory limitations in China on the exportation of matrices, which limit the analysis of these specimens to in-country resources.

    “Having regional contacts and affiliations may expedite the process. However, there is no substitute for local presence and expertise. A detailed understanding of the regulations and available options is critical to expediting study start-up, remaining on schedule, and proper resource forecasting.”

    According to Dr. Hugo, in most instances, trials planned in China have initiation and forecasting challenges resulting in start-up delays, but quick enrollment for patients, which accelerates the timeline comparative to other geographies. “This becomes an issue for long-term treatment protocols as the program milestone curve is compressed and may pose a challenge to underexperienced teams managing global programs that include China.”

    Finally, Dr. Hugo suggests that “many regional resources may have the appropriate technology, but lack experience in global project management. Or, they may have limited systems to ensure the consistency and control of the chain of specimen custody. Keeping a critical eye on these factors is key to the success of your programs.”

    Thinking outside the traditional CRO concept is the goal driving ReSearch Pharmaceutical Services. About 10 years ago, the company decided to “build the industry’s first next-generation CRO,” according to Samir Shah, vp, strategic development.

    “Our integrated business model differentiates us through our ability to deliver maximum flexibility,” Shah notes, “offering both solutions that are fully integrated with our client’s infrastructure and those that encompass more traditional outsourcing programs,” Shah notes.

    According to Shah, the company’s “fully integrated solutions allow clients to outsource those portions of the clinical development process for which the greatest efficiencies and savings can be realized, while maintaining strategic control over key medical and regulatory functions. This close collaboration means that our solutions are not limited to just one client project or protocol, but can cover the entire breadth of our clients’ drug development pipeline.

    “By embedding ourselves within our clients’ infrastructure, we create a strategic and interdependent relationship which allows us to anticipate our clients’ clinical trial demands and efficiently deploy our management and clinical team to meet the clients’ needs.”

    Shah suggests that more medium to large biopharmaceutical companies are moving toward this partnering model. “We feel that the service provider landscape, mainly traditional CROs, have to change their business model in order to be more adaptable and flexible. While the greatest growth for traditional CROs in the long term will come from smaller, virtual organizations that do not have the ability to conduct clinical trial work, CROs will have challenges meeting the needs of large- and medium-sized biopharmaceutical firms. As the industry continues to consolidate, the traditional CRO model will have impact in terms of continued growth and associated profitability.”

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