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Electronic Tools for Drug Development and Registration from a CRO's Perspective

A medium-sized CRO needs to balance their resources carefully in a rapidly changing legal environment. It is vital to have the tools available to serve the needs of both international and national clients and to fine-tune the range of services.

For the core areas of clinical operations, regulatory affairs and data management, different tools are currently available either as software on a license basis or as a service provided by specialised suppliers.

The actual scope, taking the German scenario into account, is:

e-Trials (electronic data capture, e-trial tracking and e-trial management)
Electronic 'AWB' (drug surveillance)
Electronic common technical document (electronic tools for the eCTD)

e-Trials

Electronic data capture has been discussed in numerous articles and meetings for a considerable period of time. The advantages are numerous, the most important, among others, being:

Rapidly available clinical data drives a trial forward with fast decision-making processes
To change the role of the CRA
To avoid the bottleneck for data management in the data cleaning and query resolution prior to database lock
To encourage investigators to complete the electronic case report form quickly and to ease the process of reporting


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By Dr Uwe Albrecht, Managing Director of Mediconomics GmbH and Chief Executive Officer of Mediconomics Inc

Dr Uwe W Albrecht started his professional life in 1984 at Behringwerke, Marburg/Lahn where he worked as a CRA on Phase II and Phase III trials in oncology and haematology. By the end of 1987, Dr Albrecht joined Glaxo GmbH, Germany, from which he moved on to Glaxo Group Research Ltd, London, as Senior Clinical Research Scientist in 1990. Moving back to Germany, Dr Albrecht joined Wellcome Germany, mainly focussing on drug development in virology.

In 1993, he was employed at the Institut für Gesundheitsforschung (Institute for Health Research) near Munich as Director of Clinical Research and Regulatory Affairs. From 1995 to 1997, Dr Albrecht worked as Scientific Director with Norgine, Marburg, before joining Pharmakopius International as Head of German Operations. In 1999, he joined Mediconomics GmbH, Hannover as Managing Director.

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Dr Uwe Albrecht
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