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European Pharmaceutical Contractor

The Next Major Hurdle for Electronic Data Capture: To Embrace Paper

Electronic Data Capture Today

The accessibility of the Internet combined with the mainstream use of personal computers at home and at the office have heralded a new portal for communication. The Internet has grown out of an email application into a vast worldwide network that allows the public and organisations to deposit, retrieve and exchange information at the click of a button. It was therefore inevitable that the potential use of the Internet in collecting clinical data would be exploited.

Indeed, over the last few years numerous electronic data capture (EDC) solutions from vendors have become available with each offering, characterised by varying levels of functionality, quality and cost. However, despite the potential of EDC, the majority of studies are still completed with the traditional, paper method. In fact, only 5-15 per cent of studies conducted utilise EDC (1, 2). Certainly, in those trials conducted with EDC, the usefulness and reliability of the method have been clearly demonstrated. In fact, some of the potential benefits of EDC can be summarised as follows (1-4):

Elimination of data transcription from paper CRF to database
Reduction in paper management - less paper documents (CRF and DCF) for tracking and filing
Online data validation leading to increased data quality and fewer 'late' queries
Increased efficiency in the data review process, thereby leading to increased data quality
On-demand availability of study data for project management, data monitoring and interim analysis
Faster study completion
Increased efficiency in clinical drug development


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By Dr Miklos L Schulz, President and Senior Consultant, and St Clare Chung, Director of Biostatistics and Data Management at SciAn Services Inc

Dr Schulz's professional career began at Chinoin, a European pharmaceutical company where his interest in the design and analysis of clinical trials evolved. Collaborating with a clinical research group focusing on diabetes mellitus, he completed a PhD thesis in individualised, optimal drug therapy. Following his post-graduate work, Dr Schulz worked at the Hospital for Sick Children in Toronto as a Senior Scientist conducting investigations in intermediary metabolism and diabetes, as well as designing and analysing clinical studies. Currently the President and Senior Consultant of SciAn Services Inc, he is involved in exploring the applicability of unique designs such as sequential or bayesian designs in clinical trials and designing clinical trial information and data management systems. Dr Schulz has some 30 publications to his credit in the areas of applied statistics and various therapeutic fields. His continuing research interests lie in applied biostatistics and pharmacokinetics.


St Clare Chung has a Masters degree in Statistics from the University of Waterloo. She has been working in the pharmaceutical industry for the past 11 years as a Bio-Statistician. Her statistical responsibilities include the design, analysis and reporting of Phase II-IV clinical studies, with special interest in CRM and sequential designs in oncology, obstetrics, CNS, arthritis and dermatology. She is currently the Head of the Bio-Statistics and Data Management group at SciAn Services Inc and has extensive programming experience in Lotus Notes, SAS, C/C++ and Visual Basic. St Clare was a key team member in the design and implementation of the clinical data management system that is currently in use at SciAn.

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Dr Miklos L Schulz
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St Clare Chung
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