News

An extended survey was conducted on the topic of clinical quality assurance (CQA) benchmarking in pharmaceutical companies to gather new data.

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

New requirements for clinical research teams, and administrative responsibilities and constraints for investigators conducting noncommercial trials.

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

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.

Pharmaceutical research and development costs are growing faster than the market.1 This trend is important, because pharmaceutical companies finance R&D from a relatively fixed percentage (10%?20%) of global revenues.

The process of conducting clinical trials with plasma-derived products is essentially similar to that for any pharmaceutical product. However, trials with these products do present some different challenges in terms of trial design, patient recruitment, and clinical trial supplies.

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.

Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.

The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).