Applied Clinical Trials
June 01, 2003
Feature Article
The study protocol and a set of specifications are the road map for developing the software and the support structures for an EPD study.
June 01, 2003
View from Brussels
Just like London buses, you wait for one for ages, and then a whole bunch come along at once. That's what's happened with the European Union's guidelines on how the new clinical trials rules should be applied at national level.
June 01, 2003
Feature Article
The clinical and technical teams use the protocol and a set of specifications as a road map for developing the software and the support structures for an EPD study.
June 01, 2003
Media Review
Kimberly Irvine and Eileen Hilton (CenterWatch, Boston, MA, 2003), 158 pages, paperback, ISBN: 1930624395, $39.99.
June 01, 2003
Feature Article
Planning and preparation, along with imaginative innovations, can put an investigative site on the road to best research practices.
June 01, 2003
View from Washington
FDA is exploring policies to incorporate genomic information into the regulatory process.
June 01, 2003
Technology Viewpoint
FDA surprises the pharmaceutical industry with its new interpretation of the Electronic Records, Electronic Signatures rule.
June 01, 2003
Feature Article
Economic realities are changing the way companies do business. One significant change is the growing numbers of freelancers in the clinical trials arena.
June 01, 2003
Media Review
John I. Gallin, Ed. (Academic Press, San Diego, CA, 2002), 490 pages, hardcover, ISBN: 0122740653, $99.95.
June 01, 2003
Feature Article
HIPAA?s new Privacy Rule is in effect, and sponsors and clinical research professionals are learning how to apply it.