News

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.

Mutual understanding of roles and responsibilities across the boundary between IT and clinical operations allows both departments to function more effectively.

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.

Readers share their experiences

Readers share their experience

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.

Readers share their experience

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.

Readers share their experience

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

Readers respond to articles and columnists

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

Sabritt recalls the challenge of building a data management organization from the ground up while striving to retain the pioneering spirit, flexibility, and rapid decision-making capabilities or a startup culture.

Are the virtual pharmaceutcal companies created by outsourcing and today's data-sharing technologies a sign of the industry's future direction?

Let's start taking "e" for granted and look instead at the features we really need in clinical technology applications.

An ethical quandry

Communication and Data Management Strategies & Sptlight falls on GCP Directive, Ethics in Paris

As FDA monitors more international clinical trials, new policies aim to address differences in national approaches to such issues as placebos and protocols.