Ron Keeney
At work and play, he?s devoted to children.
Clinical Research in Mexico: An Overview
The United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?
Good Clinical Practice: 10 Steps for Improving FDA GCP Inspections
European inspectors are doing a better job of implementing ICH GCP guidelines than their American counterparts at FDA. Here are 10 ways U.S. inspectors could improve their inspection process.
Nobody Knows the Costs They?ve Seen
To judge the value of process improvement, companies need to understand the cost of doing business. The problem is: they don?t.
Interpretation of Regulatory Requirements by Technology Providers: The Case for Electronic Source Data
The authors contrast two views on the regulations concerning electronic source data.
HIPAA Privacy Rule: Effect on Medical Research
An attorney who specializes in health law advises researchers and research organizations to study and put into practice the proposed changes in a rule that governs use and disclosure of protected health information.
Letters to the Editor
Readers respond to articles and editorials.
Ethical Review and the Globalization of Clinical Trials
As clinical trials become global affairs, more effort should be devoted to the protection of research subjects. However, the question of consistency among ethics committees looms.
Measuring Investigator Satisfaction
In a global survey, Roche asks investigators how to go about getting the best clinical trial sites.
European Guidelines for Auditing Independent Ethics Committees
The European Forum for Good Clinical Practice (EFGCP) put together these guidelines as a push toward quality and efficiency in ethical review practices.
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.
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.