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EDC: Quo Vadis?

To write about EDC in the year 2002 is a somewhat ambiguous enterprise. From a technical viewpoint, a proselyte of this still relatively new technique can be proud of the currently almost exploding number of publications on this topic, which makes him wonder what has been left to write about. On the other hand there are points which can't be stressed often enough, together with the need to take into account all the novelties in this fast-changing environment. From an economic and philosophical point of view, especially after the downturn of the so-called 'new economy' and the recent unpleasant revelations on 'creative accounting' in major companies, the need for positive information regarding the future of this industry is greater than ever. YES, Internet and information technology will revolutionise the clinical research industry, BUT they'll do it at different speeds and in different ways than may have been anticipated some two years ago.

EDC: the market

The market for software and services related to clinical trial processes is worth US$874 million, is growing at 17 per cent a year and will reach US$1.49 billion by 2004 (1). There is apparently a market of remarkable size, reflecting the worldwide interest in this form of clinical data management.

A multitude of different systems and solutions can be distinguished: proprietary systems, developed either by big (multinational) pharmaceutical corporations or contract research organisations (CROs) for their own purposes; 'off-the-shelf' solutions offered by software providers; tailor- made systems of medium-sized CROs, developed in conjunction with web programmers; adapted statistical software systems... a situation characteristic of a pioneering period. Each of these solutions has its distinguishing features.


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By Dr Thomas Bart, Managing Director of eCR e-Clinical Research GmbH

Dr Thomas Bart is Managing Director of eCR e-Clinical Research GmbH. He studied Communication Science and National Economy at the Technical University of Berlin and Medicine at the University of Tübingen, graduating in 1989. His clinical experience is primarily in cardiology, with a specialisation in ECG and ABPM (ambulatory blood pressure monitoring).

In 1991 he joined F. Hoffmann-La Roche, Switzerland, to work in different roles in pharmaceutical marketing and clinical research. From 2000 to 2001 he was Medical Director of Boomerang Pharmaceutical Communications, a French agency developing web-based communication programmes for pharmaceutical companies. In addition to his engagement at e-Clinical Research, Thomas is an independent consultant to the pharmaceutical industry.

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