Michelle Hoiseth, Corporate Vice President for Real-World Data Services, PAREXEL

FDA’s EHR Guidance Provides Welcome Clarity to Device Community

Medical device clinical trial practitioners might be under pressure to further raise their game, as evidenced by recent U.S. Food and Drug Administration (FDA) guidance and other moves. “There is a trend in more [FDA enforcement] rigor in devices,” says Michelle Hoiseth, corporate vice president for Real-World Data Services at PAREXEL. Hoiseth sees a number […]

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FDA Guidance Looks to Boost Generic Drug Trials

In an effort to help speed generic drugs to market—especially those addressing the opioid crisis—the U.S. Food and Drug Administration (FDA) has issued 43 new guidances, including 26 aimed at specific drugs and 17 revisions to update and streamline the generic drug trials process. “These updated guidances will make the process for developing low cost, […]

Dr. Larry Kennedy, VP for Quality Management Systems and Chief Quality Officers, ACRES

ACRES Unveils Clinical Research Site Accreditation Standards

Years in the making, with dozens of experts and entities engaged in the back and forth discussions, the Alliance for Clinical Research Excellence and Safety (ACRES) just unveiled a global quality standard for clinical research sites aimed at raising the accuracy and integrity of data input from the very beginning of the process. Too often, […]

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NIH Makes Advances in Precision Medicine Initiative Patient Recruitment

The National Institutes of Health (NIH) is lauding some successes in the early stages of its ambitious Precision Medicine Initiative, which is designed to leverage advances in genomics, in emerging methods for managing and analyzing large datasets while protecting privacy, and in health information technology to accelerate biomedical discoveries. As part of the initiative, NIH's […]

FDA Guidance Defines Proper Usage of eHealth Records in Clinical Trials

The U.S. Food and Drug Administration (FDA) hopes to “modernize and streamline” clinical investigations by promoting use of electronic health records (EHRs) in clinical trials with a new guidance providing direction on when and how to use EHRs as a data source in a trial, among other areas. The guidance is aimed at sponsors, clinical […]