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In contract research and contract bridge, the cards aren't as important as the people holding them.

To better understand the complex world of licensing and enterprise software, consider a driving analogy.

Datatrak International's Phase IV, Espicom's World Pharmaceutical Markets, and Keris, Inc.'s Vital Consent

The Uppsala Monitoring Center's WHO Drug Dictionary, Information Mediary's Med-ic Smart Package, and Relsys International Inc.'s Argus J

Daniel Callahan (University of California Press, Berkeley, CA, 2003), 341 pages, hardcover, ISBN: 0-520-22771-9. $29.95.

Readers respond to articles and commentaries.

IntraLinks' IntraLinks, Pharsight Corp.'s Trial Simulator, and Thomson CenterWatch's Drugs in Clinical Trials Database and eDirectory of the Clinical Trials Industry

May 2004 Issue Advertising Opportunity

ACRP Conference Promotional Opportunity

ACTion Newsletter logo

Art / Image Article

Medidata Solutions's Vision Developer, Gentiae Clinical Research, Inc.'s LifeSignals, and Integic Corp.'s CRF WorkManager

Arbitrarily scheduled meetings eat away at valuable time otherwise spent actually getting things done.

When FDA commenced discussions on the use of electronic records in lieu of paper records in 1991, it embarked upon a six-year consultation exercise culminating in the issuance of the final rule "21 CFR 11,"1 which came into force on 20 August 1997. The final rule itself is succinct (approximately 2000 words), but has given rise to massive amounts of commentary and interpretative text. The latest guidance aims to address issues with these secondary texts rather than the rule itself.

As so many articles have noted,1 the uptake of electronic data capture (EDC) and associated technologies has continued to be disappointing. Even though 20 years ago experts predicted that electronic case report forms (CRFs) would replace paper as a natural consequence of the introduction of computers, this has not been the case.

Disease evaluation by imaging modalities such as computed tomography (CT) and magnetic resonance imaging (MRI) is an accurate, reproducible, and easily accessible methodology used in pharmaceutical trials.

Three profiled companies have three different needs when it comes to choosing PDA.

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.