Applied Clinical Trials-09-01-2001

Applied Clinical Trials

Connecting at the Connectathon

September 01, 2001

Inside IT

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

September 01, 2001

View from Washington

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

September 01, 2001

View from Brussels

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

September 01, 2001

Notes from the Field

Readers share their experience

The Clinical Audit in Pharmaceutical Development

September 01, 2001

Media Review

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

September 01, 2001

Notes from the Field

Readers share their experience

Effective Invvestigator Meetings

September 01, 2001

Feature Article

Combining the principles of adult learning with the advantages of Web technology can engage participants in important investigator meetings.

Randomized Controlled Trials

September 01, 2001

Feature Article

New systems of ethical oversight for randomized controlled trials could ease the problems caused by increasingly cumbersome restrictions.

A New Challange for Central Laboratories

September 01, 2001

Feature Article

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

September 01, 2001

Meet the EAB

As well as being a committed European, Domenico Criscuolo is a powerful supporter of the Italian clinical research community.

Monitoring Where Others Take Holidays

September 01, 2001

Feature Article

A creative mobile monitoring model could help sponsors tap the potential of southern Europe (and Mexico) as areas for clinical research.