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Two experts share their wisdom on how to correcly apply for Medicare coverage for clinical trials.

Power source Raymond Hecker explains what's required to be 21 CFR 11 compliant, power-wise.

A dictionary of words and phrases whcih are crucial to the world of clinical trials.

Somewhere in a closed conference room, the IT wizards are plotting the data strategy of your company or institution. They are wrestling with the vast amount of raw data that is being collected and the challenges of making that data available as information to help in making decisions.

A full listing of college and university courses, training classes, and other educational opportunities.

These names, numbers, and titles are a phone directory for the regulatory world.

A listing of the alphabet soup of acronyms, abbreviations, and initials in the clinical trial world.

Find out about the purposes, rates, meetings, and publications of over two dozen socieites and associations.

Moving ineffective personnel out of critical positions can be a difficult but necessary management task.

ACT 2003 Winter Forum Conference Programme

The expense of developing electronic submissions is manageable, even in a small company, and the benefits are great for both FDA and industry.

The economic consequences of inefficient work processes in clinical trials are significant. The average daily cost of drug development runs about $30,000 per day and rises by 10% to 12% per year. Development cycle times range from three to 12 years.1 In typical operational practice, the line management of a competitive firm strives to achieve the highest volume of successful new drug application (NDA) submissions (effectiveness) in the shortest practical time (efficiency). This combination reflects the business throughput of an organization.

eClinical Trials: Planning & Implementation is a useful resource for those new to the industry as well as practitioners already involved in planning and implementing eClinical trials.

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.

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

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.

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.

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.

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

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

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.