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Maintaining Validation Control Over EDC Systems During a Clinical Study

A lot has been written about the benefits of implementing electronic data capture (EDC) in the context of clinical studies. Topics commonly covered include the regulations, guidance and standards against which EDC solutions are created and implemented, the methods for maintaining data security, and those for measuring and delivering a return on investment, not to mention the general ways in which EDC affects and improves the processes of data gathering and what the future holds.

Despite the discussion about EDC there has been limited use of the technology throughout pharmaceutical companies' development pipelines. Whilst 50 per cent of companies may claim to have used EDC, this has commonly only been in pilot phase. This level of maturity is reflected in the industry estimates that EDC is still only used in between 5 per cent and 10 per cent of studies commenced on an annual basis (1).

Companies are grappling with the practical aspects of EDC implementation in a constantly changing environment. This situation presents particularly interesting challenges for the clinical research organisation (CRO) community. CROs find themselves either trying to implement a 'standard EDC solution' or deliver flexibility to their clients. Both approaches have their limiting factors. As the market matures, perhaps the latter approach best enables CROs to take advantage of the EDC technology which proves itself to satisfy the needs of their market segment.


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By Simon Crowe, Senior Business Development Manager, Informatics & Technology Services at PPD Development, UK

Simon Crowe has spent the last seven years working with clients in the manufacturing and pharmaceutical sectors. He has helped to specify and supply appropriate computing technology to meet the need for improved management of information. During this period Simon was responsible for all commercial aspects of a start-up EDC vendor, 4th Wave Technologies. Most recently Simon has taken on the role of Senior Business Development Manager at PPD Development.
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Simon Crowe
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