Surviving an FDA Inspection of Your Clinical Trial Site

The Investigational New Drug (IND) regulations went into effect in 1963. Ever since, the U.S. Food and Drug Administration (FDA) has conducted clinical site inspections under what is known as the Bioresearch Monitoring Program. The agency now conducts several hundred inspections of clinical investigators annually to obtain compliance with the regulations and to ensure that data submitted to the FDA are substantiated by appropriate records.

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Physicians find clinical research brings income and treatment options

Trying their patients: practitioners find clinical research projects, chosen well, can create extra income and widen treatment options.

 

Phase III clinical research has the potential for eye-catching margins, but private practitioners who enter the, field with that motive seldom stay. The reason? Financial returns don't come easily, and the process is fraught with opportunities for failure.

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Emissary Technology Key to Enrolling First Patient Within 7 Days of FDA Approval of a Dialysis Graft Trial

Emissary Inc. has been selected by Novoste Corporation (Nasdaq:NOVT) to collaborate on monitoring and clinical trial management of Novoste's BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow) clinical trial.

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Emissary Key to Radiation Study Success

Looking to increase the efficiency of its recently approved beta radiation trial, Novoste (Norcross, Georgia) selected contract research organization Emissary (Austin, Texas) to run the show. Emissary's TeamTrials electronic data capture technology will be used to monitor and manage the BRAVO (Beta Radiation for treatment of Arterial-Venous dialysis graft Outflow) clinical trial.

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More Trials & Tribulations for Clinical Monitoring

Clinical trial litigation is on the rise in the drug arena, and the effects could soon spread to the device industry. The Legal Times (Washington, DC) has reported that lawsuits are increasing and often pursue every person and institution in their paths. If device manufacturers want to avoid legal action, they need to protect themselves by making sure they’re not cutting corners.

The first step is to hire the proper staff to monitor clinical trials, says Steven Mayo, president of Austin, TX–based Emissary International, a contract research organization. "America seems to be in a lawsuit craze, and the number of high-profile lawsuits seems to be increasing," says Mayo. "The class-action lawsuit trend is a negative [development] that’s really affecting [the device] industry."

Read more: More Trials & Tribulations for Clinical Monitoring