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European Pharmaceutical Contractor

Are You Ready for EDC Technology Transfer?

The use of electronic data capture (EDC) for clinical trials as an internal application by the pharmaceutical industry is continuing to gain momentum. To date, most EDC clinical trials are utilising EDC software on an application service provider (ASP) basis, meaning that the sponsor licenses the software on a trial-by-trial basis, relying on the vendor for the support functions of training, trial development, hosting and help desk, among others. Now that clinical organisations have become familiar with various EDC applications through outsourced projects, many are planning to bring this technology in-house. However, as with any software implementation project, significant planning and readiness is essential for success. At any given time there are tens of thousands of software projects taking place around the world. Up to two-thirds of projects will exceed schedule and/or budget, and of the most expensive projects, nearly half will be cancelled because they are viewed as being 'out of control'.

Successful software projects demand careful planning and deliberate execution. Conversely, software projects are more likely to fail for two reasons - lack of knowledge and/or lack of resolve to conduct software projects successfully. By fully educating yourself about what needs to take place during this transition and by carefully planning the execution, you can greatly improve your odds of success.

What

What do you hope to accomplish with EDC in-house? This question alone might give pause for thought. As a clinical trial sponsor, you most likely have EDC in the field at investigator sites and with monitors, but are you ready to design and build e-CRFs yourself? Are you able to provide hosting services for the central repository where all of the clinical data will ultimately be collected? Can you provide help desk services to address functional and/or technical questions from investigators and monitors at remote locations? Considering these questions can help you decide if you should take a phased approach to EDC implementations or bring it in-house all at once.


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By Brian Dakin, Director of the Project Management Office at CB Technologies, Inc.

Brian Dakin is the Director of Project Management at CB Technologies, Inc. He joined the organisation in 1998 and is responsible for the management of ASP trials as well as technology transfer engagements. Brian co-ordinates activities across many of the departments that provide the services necessary to support MetaTrialTM EDC-based clinical trials.

Prior to joining CB, Brian held positions in management consulting at Coopers & Lybrand and Ernst & Young, with a focus on systems implementation and process improvement. He has a BS in Industrial Engineering and an MBA from Lehigh University.

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