By Deb Borfitz
April 19, 2010 | International biopharmaceutical firm Cephalon, Inc. has transferred its U.S.-based data management staff to BioClinica, Inc. as part of a multi-year outsourcing deal with the electronic data capture (EDC) provider. The unprecedented move gives BioClinica the lion’s share of Cephalon’s data management work as well as an enriched human resource pool deployable to other projects and customers, says BioClinica President and CEO Mark Weinstein. The deal also makes BioClinica’s web-based ExpressTM the default EDC system for Cephalon-sponsored clinical trials.
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| Peter Benton |
Specific tasks being outsourced to BioClinica include data management planning, clinical study set-up for EDC, medical coding, adverse event reconciliation, clinical data management, and training of clinical sites and investigators.BioClinica (formerly Bio-Imaging Technologies) acquired EDC capabilities with its March 2008 acquisition of Phoenix Data Systems, with whom Cephalon began working five years earlier. Data management services have increasingly been coupled with ExpressTM per the preference of sponsor firms, says Peter Benton, president of BioClinica’s eClinical Services Division. The company currently provides some level of data management for more than half of its EDC clients. Their other alternatives are to outsource the work to a full-service clinical research organization (CRO), “staff above expectations” internally, or work overtime to deal with periodic but inevitable data surges.
“Certainly no one knows EDC and our ExpressTM platform better than BioClinica’s data management team,” says Benton. “They work with [ExpressTM] all day long and know all they can about what can go wrong and right with the design of a clinical study. There is little they’ve not seen.”
For Cephalon’s data management team, the transition to BioClinica was seamless. The same people are doing the same work on the same studies, just in a different location, and they’re “excited” by the prospect of working on projects beyond Cephalon, says Weinstein.
BioClinica will essentially be an “extension” of Cephalon’s standardized drug development process and work with other functional service providers to optimize operational efficiencies, says Benton. “Cephalon is one of the companies that ‘gets’ it and has embraced a better way of running clinical trials.”
More data management deals, with or without the employee transfer feature, might be on the horizon for BioClinica. “Many of the key decision makers at small- and mid-size pharma companies formerly worked for larger firms that owned and managed non-core services like data management and the associated IT infrastructure,” says Weinstein. “They know that’s what they don’t want.” In fact, most would prefer to be “virtual” and only contract for the work as needed.
The “full service” strategy is a differentiator for BioClinica, as both the smaller and the larger EDC players are generally technology-only vendors. CROs are the traditional purveyors of data management services, but sponsors are forced to switch platforms every time they switch CRO partners, says Benton. “Can you imagine switching your finance system every time you outsourced another trial? The benefit of using BioClinica is…[that sponsors] can run their trials their way, the same way, every time. That’s the secret to running an effective development organization.”
Sponsors want to standardize to a single clinical business process and platform, even if they use different CRO partners, continues Benton. To do otherwise breeds inefficiency and can significantly, but unnecessarily, increase study start-up times. “If you keep changing [technologies and processes] trial to trial and compound to compound, you have to keep re-learning the same things over and over.”