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Accelerating Phase I Clinical Trials: Using CDISC Operational Data Model Study Specifications and High-Speed Translators to Auto-Generate Fully Featured Electronic Data Capture Systems

Electronic data capture (EDC) has been proposed as a viable technology solution to paper data capture in clinical studies for over 15 years. From the early remote data entry systems to advanced third generation software solutions, everyone sees the benefits of reduced query rates, shortened database lock times and greater data visibility. Today, modern EDC solutions have had a marked effect on these key metrics, and some major pharmaceutical companies see electronic trials as the only logical way to conduct studies.

However, despite substantial process improvements in 'back-office' data management processes, many of today's EDC solutions have failed to address the whole eClinical process from protocol creation through to final submission. The study set-up process has been particularly neglected and whilst this may have been inefficient with paper it is now torturous with electronic trials.

Significant reductions in database lock time are great, but these systems can take anywhere between four to 10 times as long to set up and build when compared with traditional paper-based studies. There is a real need for study specification and production technologies that ensure that EDC systems can be built in very short timeframes consistently in order to handle the high volumes of Phase I studies conducted annually. This article discusses using study specification and production technology solutions based on the vendor neutral, platform independent industry data standard proposed by the Clinical Data Interchange Standards Consortium (CDISC) (1).


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By Peter Barrie, Technical Director and Mark Wheeldon, Chief Executive Officer at Formedix

Peter Barrie is Technical Director at Formedix Ltd and is responsible for the development teams of software engineers and clinical research specialists. He also oversees software-testing activities and has been instrumental in the development of quality systems and 21 CFR Part 11 compliance. Prior to joining Formedix, Peter spent 18 years in academia, lecturing on a wide range of computer science topics and programming languages. He holds a BSc (Hons) and an MSc in Computer Science from the University of Strathclyde, UK.

Mark Wheeldon is Chief Executive Officer at Formedix Ltd. Mark is an active supporter of CDISC and is a member of the CDISC Industry Advisory Board (IAB) and strategic taskforce, believing strongly that the future of clinical data management and regulatory review lies firmly in the successful implementation of data standards technologies. He holds a BSc (Hons) in Pharmacy from the University of Strathclyde, UK.
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Peter Barrie
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Mark Wheeldon
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