News

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Vocel's mDiary, Clinical Systems, Inc.'s ClinBook, and Provisio Inc.'s iTrials

Insider Trivia

Find out all you need to know about the District of Columbia to impress colleagues and clients.

From the Publisher

Welcome to ACT's Washington DC Exhibitor Profiles Supplement for 2004.

A United Nations of taste buds is a mere walk or short cab ride from your hotel. Here are some highlights to whet your appetite.

Family Fun in DC

With so many enjoyable and educational opportunities at hand, keeping your spouse and children occupied is an easy task. The dilemma is deciding what to do first!

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Clinical trials in developing nations-called "ascending markets"-are exploding. These regions offer large naïve subject populations, low operating costs, and increasingly stable testing infrastructures, but regulatory reform is really driving the growth. CenterWatch data show 20%?30% of clinical trials are being conducted in ascending regions.

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

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

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

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

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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.

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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.