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Future retrieval of vital clinical data depends on having a strategy to deal with the rapid obsolescence of computer software and hardware.

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Tremendous changes in the capabilities of EDC technology and the capacity of EDC vendors make electronic data capture a reliable tool for significant business advantage.

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Whether formally accrediting IRBs will benefit research subjects?or simply create more paperwork?remains to be seen.

Addressing the unnacceptable lack of pediatric labeling requires not only economic incentives but also an understanding of the unique difficulties involved in pediatric studies.

David Bowers, Allan House, and David Owens, School of Medicine, University of Leeds, UK

Web-based ESA applications provide an infrastructure that can improve the success rate of outsourcing relationships.

Moving between the UK and Switzerland, and between academia and industry has given Editorial Advisory Board member and statistician Stephen Senn a well-rounded view of pharmaceutical development.

Wireless computing may be the way of the future, but several obstacles currently prevent us from achieving it.

Investigators are sometimes eager to open a subject?s blinding code when they perceive a medical emergency. Informing investigators about expected adverse events can forestall these requests.

Getting answers to the right questions can help you decide how to choose and implement an electronic system that is a good match for your company's SAE reporting needs and its available resources.

A systematic survey of 96 pharmaceutical companies and clinical research organizations revealed which systems sponsors are using for clinical data management and adverse events tracking and reporting.

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CDISC has broad support for its fledgling standard whose evolution is critical to the acceleration of technology adoption in clinical trials.

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Michael R. Hamrell, PhD, Ed., (Drugs and Pharmaceutical Sciences, volume 104, Marcel Dekker, New York, 1999), 224 pages, hardcover, ISBN 0-8247-0309-X, $135.

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Combining the principles of adult learning with the advantages of Web technology can engage participants in important investigator meetings.

New systems of ethical oversight for randomized controlled trials could ease the problems caused by increasingly cumbersome restrictions.

EN ISO/IEC 17025 is more evidence that international standards are evolving to keep pace with technology and improve the performance of accredited central laboratories.

As well as being a committed European, Domenico Criscuolo is a powerful supporter of the Italian clinical research community.

A creative mobile monitoring model could help sponsors tap the potential of southern Europe (and Mexico) as areas for clinical research.

A public key infrastructure (PKI) can make it possible to securely exchange data on the Internet. This introduction will help you understand the issues in PKI implementation.

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Outsourcing and data-sharing technologies are creating virtual pharmaceutical companies. Soon, you may be only as good as your network.

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Maintaining minimum standards can compromise the quality of your data and the rights and safety of study subjects.