News

Readers respond to articles and editorials.

Clinical trial samples can be dangerous or infectious. With regulators and airlines cracking down, you should know the rules for their transfer and transport.

Eli Hauser and Paul Bleicher No matter how much a company spends on risk management, it can never prevent all loss. But setting priorities and establishing a risk management strategy can minimize the potential consequences.

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

Readers share their experiences

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.

Readers share their experiences

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.

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

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

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