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.
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
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.
Public Key Infrastructure: The Beginning of a Beautiful Friendship?
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.
