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International Clinical Trials

The Happy Couple

Katrien Vermeiren of SGS Life Science Services explores the relationship between EDC and CDISC – the perfect combination for successful submission

Since electronic data capture (EDC) has become a valid alternative to paperbased trials, we are frequently confronted with the problem of trial-specific database structures, which are inherent to EDC. The lack of regulated standards makes inter-departmental and inter-organisational collaboration difficult. A standard database structure, as prepared by the submissions data standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC), would certainly facilitate the collection, exchange, reporting and submission of clinical data. Ideally, the EDC provider would deliver a standard structure. However, SDS interpretation differences, the impact of database structure changes on the eCRF and the increasing amount of work upfront are important objections to this approach. Leaving the SDS conversion up to the sponsor or CRO seems the best solution – a close collaboration between the EDC provider and the sponsor or CRO should be encouraged.

ELECTRONIC DATA CAPTURE

EDC has been proven to reduce the cost of clinical research studies by improving quality and reducing the time to database lock. It can also accelerate the development time of a particular drug (1).

EDC enhances the visibility of clinical data, resulting in better data control and making faster interim analysis possible. The system enables companies to dynamically modify the management of allocated resources and trials. Moreover, EDC also seems to be a promising system for accurate operational metrics (2), which in turn helps to reduce the time-to-market and the cost of new medications.

With these benefits in mind, one can overlook the need to investigate the problems inherent to EDC. Ad hoc and informal trial specification methods, coupled with the lack of standardised data interchange formats, mean that study set-up and execution will continue to be problematic, timeconsuming and expensive. The lack of globally accepted pharmaceutical data formats is believed to cost the pharmaceutical industry in excess of US$156 million per annum (3).


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Katrien Vermeiren is Programming and Data Entry Manager within the biometrics department at SGS. Prior to joining SGS, Katrien Vermeiren worked at Janssen Pharmaceutica as a Clinical Data Co-ordinator in the oncology field, and as a Data Reviewer at MSI (now SGS). With three years of data review experience, she joined the programming group as Data Manager, where she mastered the relevant data management skills. As well as her Programming and Data Entry Manager activities, Katrien now focuses on implementing EDC technology within SGS.
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