Identifying and Documenting Adverse Events at Clinical Study Sites
Improving adverse event reporting can lead to improved safety profiles and, consequently, fewer drugs pulled from the market.
Brian Koziol
Family man, educator, mentor, athlete--and a man on a quest with Amgen Inc for new and better oncology treatments.
A Model-Based Method for Improving Protocol Quality
A new method, based on hard-earned experience, can help you reduce the risk of protocol inconsistencies and ambiguities during the protocol development process.
A Multidisciplinary Approach to Data Standards for Clinical Development--Progress Update
The pharmaceutical industry spends more than $156 million each year to support data transfer, and all involved parties could benefit from common interchange standards.
When Process Improvement is Skin-Deep
Many re-engineering projects neglect the nuts and bolts that are needed to make strategies a reality.
Consider Geography When Choosing Investigative Sites
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.
Meet the Editorial Advisory Board Francis Crawley
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
Selecting Sites and Investigators
The system is an important part of the selection equation in CEE nations where sponsors must contract with institutions rather than investigators. Examples from Hungary offer guidelines for improving selection SOPs.
Letters to the Editor
Readers respond to articles and editorials.
Data Delivery During Crisis
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.
Diamonds May Be Forever, But Data?
Future retrieval of vital clinical data depends on having a strategy to deal with the rapid obsolescence of computer software and hardware.
EDC, RDE, OCR: We speak the same language–or do we?
Readers share their experiences
Palm Pilot Software for Clinical Research Professionals
Understanding Clinical Papers
David Bowers, Allan House, and David Owens, School of Medicine, University of Leeds, UK
Enterprise Services Automation Software
Web-based ESA applications provide an infrastructure that can improve the success rate of outsourcing relationships.
Stephen Senn
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 Data: Challenges in the New New Economy
Wireless computing may be the way of the future, but several obstacles currently prevent us from achieving it.
Serious Adverse Event Reporting
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.
Clinical Research Software
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.
Planning an EDC Clinical Trial
Connecting at the Connectathon
CDISC has broad support for its fledgling standard whose evolution is critical to the acceleration of technology adoption in clinical trials.
FDA Warning Letters
Readers share their experience
The Clinical Audit in Pharmaceutical Development
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.
What a Form 483 Really Means
Effective Invvestigator Meetings
Combining the principles of adult learning with the advantages of Web technology can engage participants in important investigator meetings.
Randomized Controlled Trials
New systems of ethical oversight for randomized controlled trials could ease the problems caused by increasingly cumbersome restrictions.
A New Challange for Central Laboratories
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.
Domenico Criscuolo
As well as being a committed European, Domenico Criscuolo is a powerful supporter of the Italian clinical research community.
Monitoring Where Others Take Holidays
A creative mobile monitoring model could help sponsors tap the potential of southern Europe (and Mexico) as areas for clinical research.
