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European Pharmaceutical Contractor

Electronic Data Capture - Paving the Way for Successful Clinical Trials

Electronic tools have become more and more important in clinical research over the last few years. As the 'half life' of hardware and telecommunication infrastructure technologies has been shortened during the course of the last decade, extremely quick and reliable electronic data capture (EDC) systems have become available. Today's assortment of Internet- or intranet-based online, offline or hybrid systems allows the implementation of trials with electronic CRFs (e-CRFs) in most countries of the world.

About 15 years ago the pharmaceutical industry started to employ EDC systems in clinical trials. At this time technical infrastructures were unreliable; global networking was still in its infancy; hardware was relatively slow and expensive; and software was hardly programmed with the end user in mind. In addition, the 'landscape' created through EDC was full of pitfalls and uncharted regions not known to the 'olde paper world'. Survival was tough and led to bad experiences for companies - sometimes with lasting effects.

Today, with the help of an 'IT survival kit', a guidebook, and a 'map' of the 'electronic world', these problems can be solved. In a time when online banking and e-commerce are part of everyday life, there are some pharmaceutical companies still in the process of thinking about introducing e-CRFs, while others are implementing new generations of EDC systems based on years of 'hands-on' experience with either home-made or vendor's software.


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By Wolfgang J. Oestreich, Managing Director of Dr Oestreich + Partners

For over 10 years, Wolfgang J. Oestreich has been CEO of Dr. Oestreich + Partner, a pharmaceutical research and marketing company located in Cologne, Germany. Prior to this he was Director of Medical Development with Janssen Pharmaceutica and Johnson & Johnson for nearly 10 years. He studied at universities in Germany and the US.

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Wolfgang J. Oestreich
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