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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

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    MDS Pharma Services’ central lab operation in Beijing moved to a new facility a few years ago, tripling the size and increasing testing capacity fivefold over the previous location.

    The pharmaceutical industry is, without a doubt, feeling the crunch of skyrocketing costs, lackluster pipelines, and drug safety issues. Clinical professionals need to do more with less, while still maintaining the highest levels of quality. Many companies are choosing contract research organizations (CROs) as a cost-effective strategy to outsource services ranging from drug development to managing and monitoring clinical trials.

    The “18th Annual Partnerships with CROs and Other Outsourcing Providers” conference will be held next month in Orlando. The meeting will examine critical issues in clinical outsourcing partnerships such as improved methods of data integration, business partnering, and comparing global sites for clinical trials.

    Biotech and pharmaceutical companies often choose CRO suppliers and the required central labs independent of each other. The ultimate goal of outsourcing is to achieve three project drivers: efficient use of time, high-quality products, and mutual value-based cost (i.e., the price charged is equivalent to the value of the service provided), according to Cathy Michael, executive director project and data management, global central labs, PPD. Separate providers, however, can only achieve two, and that has been traditionally considered acceptable.

    “We feel it is possible to achieve all three goals by using a central lab already associated with a CRO. When data management is provided in this way there is  more accurate communication among all parties and all sites. For example, Michael says, “there may be multiple times a day when data, protocols, and other information needs to be added to or accessed from the various databases held at the CRO, third-party labs, and central lab. About six months ago we developed an Oracle-based system that integrates and refreshes applicable data between our CRO and central lab.”

    An important benefit of such integration is the ability to input patient data and visit it quickly via a common format that supports real-time data cleansing of patient data traditionally held in multiple repositories. “The need to reconcile at the end of a study is moot when you have one central repository allowing for a single reconciliation effort for lab and CRO.”

    Michael has some advice for companies about to choose a CRO. “It is most important to look at how companies integrate databases and to develop a long-term relationship from beginning to end with how data is captured and processed. You’re more likely to avoid costly data-integration problems later, if you do this up front.”

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