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Improving adverse event reporting can lead to improved safety profiles and, consequently, fewer drugs pulled from the market.

Family man, educator, mentor, athlete--and a man on a quest with Amgen Inc for new and better oncology treatments.

A new method, based on hard-earned experience, can help you reduce the risk of protocol inconsistencies and ambiguities during the protocol development process.

The pharmaceutical industry spends more than $156 million each year to support data transfer, and all involved parties could benefit from common interchange standards.

Many re-engineering projects neglect the nuts and bolts that are needed to make strategies a reality.

Technology can do only so much; understanding human behavior and psychology is the key to improving your communication skills.

An essential aspect of selecting the location for an investigative site is the population surrounding it. Here is a method for determining how many potential subjects are available to your investigators.

Through open discussion and dialogue, and by promoting understanding and trust, Crawley?a longtime member of the European Forum for Good Clinical Practice?champions ethical research.

9th ACT European Summit

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.

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

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