What a Form 483 Really Means
Readers share their experience
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.
Clinical Research Training on the Web
The Virtual Organization: Is It the Future Industry Landscape?
Outsourcing and data-sharing technologies are creating virtual pharmaceutical companies. Soon, you may be only as good as your network.
Letters to the Editor
Readers respond to articles and columnists
Do You "Go the Extra Mile" or Adopt a Minimalist Mindset
Maintaining minimum standards can compromise the quality of your data and the rights and safety of study subjects.
David Sabritt
Sabritt recalls the challenge of building a data management organization from the ground up while striving to retain the pioneering spirit, flexibility, and rapid decision-making capabilities or a startup culture.
The Virtual Organization
Are the virtual pharmaceutcal companies created by outsourcing and today's data-sharing technologies a sign of the industry's future direction?
Guest Editorial
Let's start taking "e" for granted and look instead at the features we really need in clinical technology applications.
An ethical quandry
Conference Reports
Communication and Data Management Strategies & Sptlight falls on GCP Directive, Ethics in Paris
Affairs of State
As FDA monitors more international clinical trials, new policies aim to address differences in national approaches to such issues as placebos and protocols.
Pen-Based Computing
A new tablet computer shows promise of achieving the functionality and flexibility that clinical trials professionals require, but computers that can recognize the wide variety of handwriting remain elusive.
Communication Skills for Monitors—A Vital Training Opportunity
Effective communication skills, which are often overlooked in CRA training programs, can profoundly affect the efficiency of a trial and the reliability of its results.
ACT 101 Human Safety in Clinical Research
Pharmaceutical companies must pay close attention to the safety of human subjects at every stage of drug development, as explained in this QA view of the policies and regulations that make the system work.
Maximize Information Flow
When outsourcing clinical supply activities, you can improve communications efficiency by integrating your supplier's organization system with your own.
