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.
Patient Demands vs. Product Development
As the public clamors for early access to promising new drugs, sponsors worry about the consequences of experimental therapy conducted outside of controlled trials.
EU Proposes Authorization Changes
Patients, research companies, and regulatory authorities may all benefit from proposed changes to current pharmaceutical legislation, but the proposals will provoke much debate.
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.
