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| home > epc > autumn 2003 > electronic tools for drug development and registration from a cro's perspective |
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 PUBLICATIONS |
European Pharmaceutical Contractor
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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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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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“PACK DIFFERENT” with EMBALLAGE 2008
“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
More info >> |
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