Study Conduct

NPR Interviews David DeMets on Drug Safety Monitoring Boards

Tuesday, June 13, 2006

In the wake of Vioxx and the recent events during the German biotech TeGenero AG’s trial, involving a severe immune reaction in six British subjects given an investigative monoclonal antibody, the industry has made a major effort to review trial safety precautions. Among other areas under scrutiny, the work of independent review boards (IRBs) has received much attention. Recently, the roles and challenges of Data Safety Monitoring Boards (DSMBs) have also been discussed in preventing further safety issues during clinical trials AND after market approval…

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Rising Stars in the Central Labs Market

Thursday, May 11, 2006

Last month, the first part in our two-part series on the central laboratory market discussed its role in the global pharmaceutical outsourcing industry and reviewed the industry’s current market share distribution and revenue forecasts. Estimates now show that the clinical trial central laboratory market is growing at a double digit pace; roughly 13% a year for the next four years.

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Covance Boosts Phase I/IIa Capacity

Sunday, April 30, 2006

The search for top quality phase I sites just got even harder as Covance, a leader in the hot early clinical development arena, entered into a definitive agreement to acquire eight early phase clinical development sites from Radiant Research, a site management organization that owns 30 sites, for $65 million. Covance is paying about 2.5 times revenue for the eight sites, which generate $25 million in annual revenue. Seattle-based Radiant Research will continue to operate its phase II through IV sites,but employees associated with the eight phase I sites will become Covance employees. Covance, one of the top global contract research organizations (CROs), has more than 7,300 employees worldwide.

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