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Another Wave of U.S. Site Acquisition Imminent

Experienced, U.S.-based investigative sites may remember the mid-to-late 1990s, when venture-backed companies were on a buying spree to build site management organizations (SMOs). That era may seem long gone, but signs now point to a new wave of acquisitions and consolidation looming. And this new wave may very well be driven by the most unlikely of sources: large European SMOs.

Are IRBs Ripe for an Overhaul?

As frustration with the expansive mission and bureaucracy of Institutional Review Boards (IRBs) builds, it has become clear that the current system for protecting research subjects needs a radical overhaul. But the system has evolved throughout the years into a complex web of agencies with differing agendas, which makes significant change unlikely without some type of federal mandate to critically evaluate the system or the development of a centralized oversight process.

Eye On Gilead

The stated mission of Gilead Sciences is to discover, develop and market novel therapeutic drugs in areas of unmet need that will improve care for patients with life-threatening illnesses. Specifically, Gilead aims to develop agents that are significant advancements over currently available products because of improved modes of delivery, more patient-friendly treatment regimens and fewer adverse effects promoting compliance, better resistance profiles, and greater efficacy.

Also in this issue:

• Latino Recruitment: Tailor Your Approach to Reach Goals
• How to Budget for Your Site
• 2010 Year in Review
• The Pulse on Recruitment
• TrialWatch
• New Study Launches