News

Earlier this year, Applied Clinical Trials published "Clinical Monitoring: Answers to Questions about Good Clinical Practice," another excerpt from the book, Good Clinical Practice: A Question & Answer Reference Guide. Readers are referred to the July 2003 issue (pages 27-29) to read the full text of the reference guide introduction.

Relatively few people are familiar with the software design process, but many have had their homes remodeled; the two processes are more similar than dissimilar.

Interactive voice response systems are commonly used in clinical trials to manage the flow of trial medication supplies to sites and to manage the allocation of these supplies to individual subjects. Other advantages and uses include access to real-time information for trial managers, collection of diary card data directly from subjects, and as an aid to subject recruitment.1

Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.

It is increasingly important for clinical trial personnel to break through the obstacles that language and culture present when conducting trials away from their home countries.

Restrictive regulations and cultural differences make regulatory approval in Japan elusive, but adopting new strategies may make that lucrative pharmaceutical market more accessible to non-Japanese companies.

Application, software, Web-based solutions, and more.

Interdepartmental politics can suffer from competition and mistrust, but for clinical trials to be truly efficient these obstacles need to be replaced by respect and purpose.

Information Showcase

Now that FDA is enforcing its Electronic Records, Electronic Signatures rule many pharmaceutical companies are reconsidering their data systems.

Bayesian isn?t the most popular statistical method yet, but it is gaining ground in a number of clinical trials areas.

Both large and small pharmaceutical companies have learned that the value of their development candidates increases once clinical research has demonstrated their proof of concept. Sponsor companies face the challenge of moving new blockbuster drugs to market as rapidly as possible.

A newly published reference guide answers a wide variety of GCP questions.

CRAs now have to monitor sites? compliance with FDA?s Electronic Record, Electronic Signatures regulation.

When you're not at the conference center or your hotel, the city offers a wide variety of things to see and do.

Here's a back stage peek at the 39th annual DIA meeting and its organizers.

Things To Do and See in San Antonio

All that sightseeing can work up an appetite, but you might not understand the menus without this guide.

The study protocol and a set of specifications are the road map for developing the software and the support structures for an EPD study.

John Vogel, clinical researcher turned consultant, is passionate about outsourcing. He believes that pharmaceutical companies can gain competitive advantages through drug development outsourcing.

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.

Kimberly Irvine and Eileen Hilton (CenterWatch, Boston, MA, 2003), 158 pages, paperback, ISBN: 1930624395, $39.99.

Planning and preparation, along with imaginative innovations, can put an investigative site on the road to best research practices.

FDA surprises the pharmaceutical industry with its new interpretation of the Electronic Records, Electronic Signatures rule.

Economic realities are changing the way companies do business. One significant change is the growing numbers of freelancers in the clinical trials arena.

John I. Gallin, Ed. (Academic Press, San Diego, CA, 2002), 490 pages, hardcover, ISBN: 0122740653, $99.95.

HIPAA?s new Privacy Rule is in effect, and sponsors and clinical research professionals are learning how to apply it.

ACT's 11th annual guide highlights applications, software, Web-based solutions, and more.

For years, EDC providers have claimed that the technology can increase efficiency and potential cost savings. Survey results indicate that clinical monitors agree.

Postmarketing research is conducted differently than preapproval research, but data gained using different standards can be difficult to integrate.