Global News

Datatrak Forms Enterprise Relationship With GP-Pharm

Tuesday, December 5, 2006

Cleveland, Ohio-based eClinical company Datatrak has formed an enterprise relationship with GP-Pharm, a Barcelona,Spain-based pharmaceutical company focusing on the development of hormonal and cytotoxic drugs. GP-Pharm is a part of the Lipotec Group, a Spanish-owned biochemical manufacturer and supplier of pharmaceutical, cosmetic and food ingredients. Initially, the contract calls for the company to use Datatrak’s EDC Version 4.0 product for a block of five clinical trials enrolling 730 patients and 145 sites. The trials are expected to be conducted in the next 14 months.

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Top Stories for the Week of Dec. 4th, 2006

Tuesday, December 5, 2006

Top News

AstraZeneca to Use Medidata’s eClinical Solutions for All Clinical Trials

The New York, N.Y.-based eClinical company Medidata Solutions has been awarded a major contract from AstraZeneca to provide the company with its Medidata Rave electronic data capture (EDC), replacing AstraZeneca’s present in-house system.

Covance Opens New Phase I Facility in Hawaii

Expanding to meet a growing demand to conduct special trials in specific ethnic patient populations, New Jersey-based contract research organization Covance has opened a new clinical research facility in Honolulu.

Other breaking news…

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The FDA On Madison Avenue

Wednesday, November 29, 2006

The Food and Drug Administration (FDA) has a deal in place that for the first time would allow pharma companies to pay fees for the FDA to review their drug advertisements. It is all being done in the hope of faster reviews. It’s not such a bad idea.

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eClinical Market Has Strong Year

Monday, November 27, 2006

In its third quarter, Morrisville, N.C.-based eClinical service provider etrials reported 40% growth in services revenue to $4.4 million.Net revenues during the same period in 2005 were $3.2 million. The company reported operating income of $178,331 compared with an operating loss of $148,618 in 2005 during the same period. etrials went public in 2005 in a reverse merger.

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FDA Proposes New Regulations for Expanded Access to Investigative Drugs

Tuesday, November 21, 2006

The U.S. Food and Drug Administration (FDA) has submitted two regulatory proposals that would expand the rules concerning who has access to investigative treatments. The new proposals would provide a clearer pathway for certain critically ill patients so they can be considered for access to investigative drugs without enrolling in a clinical trial.Both proposals have been submitted to the Office of Management and Budget (OMB), where they will be reviewed for approval.

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