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European Biopharmaceutical Review

EDC - The Key to Success

lectronic data capture (EDC) for clinical trials has been around in one form or another for a number of years with the technology continuously evolving over this time. Although low volume or pilot usage of EDC does not yield the full benefit of this technology, increasing confidence in the technology together with the operational benefits highlighted by some companies (1) is leading most companies to set EDC adoption targets with 60 to 90 per cent of new study starts by 2006 not being atypical (2).

Because full ROI on EDC usage is not realised until EDC is the default means of running a clinical trial, breaking out of low volume or pilot usage of EDC frequently requires a leap of faith. As more companies take the strategic decision to scale their use of EDC, the EDC life cycle will move from its current position where it is really only the early adopters that are taking full advantage of the benefits of the technology. In addition to the leap of faith, a strategy and plan are required in order to effectively overcome the inertia caused by the existing organisation and application set. Processes, organisation and technology should be included in the strategy for scale up. EDC software selection directly affects (or is affected by) the technology strategy. The software selected, in turn, will have an impact on processes, organisation, logistic and training strategies.


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By Colin Spink, Industry Specialist at IBM Business Consulting Services and Brent Cliveden, Vice President of Operations North America at InferMed Ltd.

Colin Spink, BSc, MPhil, MIEE, CEng has worked with IBM for 15 years, focusing on the pharmaceutical industry for the past 12. He has been specialising in clinical development for six years, working on numerous client engagements over this time. Colin's particular area of interest is electronic data capture in clinical trials and he is also the author of White Paper Realising the Full Rewards of Electronic Data Capture.


Brent Cliveden is Vice President of Operations (North America), at InferMed Ltd, and is responsible for extending InferMed's sales activities from Europe into the US and Canada and for supporting consultancy and project management services in that region. During the 10 years before joining InferMed, he worked for several other EDC vendors, as well as being a Principal at IBM Healthcare Consulting & Services, and Practice Leader for IBM's Clinical Trials Solutions Group.

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Colin Spink
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Brent Cliveden
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