Strategies for Placing CRO Offices in Europe
In Europe, U.S. CROs aren?t doing as well as they could. Where they locate their offices could make the difference.
Letters to the Editor
Readers respond to articles and editorials.
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.
Communicating in the Information Age: It?s Still All About Human Behavior
Technology can do only so much; understanding human behavior and psychology is the key to improving your communication skills.
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.
Transporting Clinical Trial Samples
Clinical trial samples can be dangerous or infectious. With regulators and airlines cracking down, you should know the rules for their transfer and transport.
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
Realize Maximum Value When Implementing Electronic Data Capture
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.
Palm Pilot Software for Clinical Research Professionals
IRB Accreditation and Human Subject Protection
Whether formally accrediting IRBs will benefit research subjects?or simply create more paperwork?remains to be seen.
Authorities Recognize a Need to Encourage Pediatric Drug Development
Addressing the unnacceptable lack of pediatric labeling requires not only economic incentives but also an understanding of the unique difficulties involved in pediatric studies.
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.
Bridging the Gap Between IT and Clinical Operations
Mutual understanding of roles and responsibilities across the boundary between IT and clinical operations allows both departments to function more effectively.
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.
Educating Investigators to Understand When to Break the Blind
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.
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
