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Transformation from Paper to Electronic Clinical Trials - The Site Perspective

Rising competitive pressures are forcing the drug development process to work at a faster and more efficient pace, shortening development cycles and increasing the demand for shorter data collection times. In response to this challenge, according to the Forrester report (1) in July 2001, more than 50 per cent of trial professionals would prefer to conduct clinical trials using web-enabled systems in place of paper and two-thirds think sponsors should make this change happen now.

The first stage in the successful implementation of a web-based trial process at the clinical investigation site is providing encouragement for the evolution of the users' mindset. If the process is continuously equated to a paper-based trial, problems will inevitably arise. We need to promote a new working environment at the user level, and introduce the new process at a rate and level appropriate to that of the user's previous experience, current resources and organisational culture. It is preferable to integrate the electronic concept gradually into the existing practice - this is an intricate challenge!

To maximise efficiency in a paper trial, the standard site's working ethos has evolved to working with batches of patient data. In contrast, e-trials often dictate that immediate data entry is required - resulting in the co-ordinator working on a 'per patient' basis. The difference in processing requirements between paper and electronic studies should be resolved during the study initiation or site set-up, to prevent unnecessary conflicting expectations within the study teams. Communication charts are particularly useful as more individuals become involved in e-trials (including technical support, help desk personnel and clinical staff).


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By Paul Webb, Commercial and Operations Director, and Nigel Trim, Managing Director of MATRIX contract research Limited

Paul Webb was appointed Commercial and Operations Director in 2000 with responsibility for bringing improved technology utilisation to MATRIX contract research Limited and its clients. He has over 12 years' experience of EDC, change management and business process re-engineering, gained through consultancy work with the world's leading aerospace and defence corporations.

Nigel Trim, a Pharmacologist, is Managing Director of MATRIX contract research Limited. He has previous experience as managing director of a medical IT company and of senior management in International Sales and Marketing, with particular experience in the use of the Internet, clinical research, the management of direct sales, global distribution networks, and in and out-licensing.


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Paul Webb
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Nigel Trim,
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