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Outsourcing Clinical Operations: Sound Bites from ClinTech 2013

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There’s no question that clinical research outsourcing is here to stay; faced with tight trial budgets and increasing trial complexity, many sponsors choose to conduct trial operations in partnership with clinical research organizations (CROs). However, handing over trial management, execution and overall performance to a third party is risky, especially knowing that all trials run into obstacles at one point or another. A shared sentiment among participants at CBI’s ClinTech 2013 conference this March was the need to improve how information is exchanged between partners to make collaboration easier. “Recently, the lines between when the sponsor processes end, and CRO processes begin, are blurred—for example, CROs are becoming part of the design process, which has not been the case until recently,” described one sponsor at ClinTech this year. “It’s more important now than ever before that partners work to ensure alignment.” Yet, at a time when collaboration is paramount and the “virtual sponsor” is more common than ever, interactions between partners are still difficult to manage using today’s manual processes and disparate clinical systems. Many CROs provide information to their sponsors via weekly emailed reports, which contain information about trial operations from their clinical trial management system (CTMS). “Sponsors end up duplicating 20-25% of what the CRO does,” by wasting time rekeying data, trying to aggregate data and maintaining multiple spreadsheets, as one consultant at ClinTech stated. The cost of legacy processes is far greater than only the duplication of effort: copying and pasting operational data into spreadsheets can introduce errors which limits data quality, while the use of pdf reports—potentially from more than one CRO—make it very challenging for sponsors to deduce trends or make data-driven decisions that keep trial progress on time. “Receiving reports from our CRO partners and then reentering the data into our CTMS is just duplicating work that the CROs have already done. This wastes a significant amount of time and resources, and most recently has resulted in staff attrition,” expressed another sponsor at ClinTech. Today’s life sciences companies want to be better outsourcers, and they need solutions that support collaboration and compliance (for less than they were spending five years ago). One ClinTech participant advocated that the way forward is for outsourcing partners to build an ecosystem of interoperable technologies that can be used to exchange information, but expressed that the cost of system integrations have been holding our industry back. Will building data standards enable a cost-effective way forward? Guest blogger Laurie Falkin is a manager, product marketing at Medidata Solutions. You can reach Laurie via email or follow her on Twitter @LaurieFalkin.

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