Showing items tagged as clinical research organization (CRO)

  • 2018-bl-thumb-mc-top-clinical-pharma-bio-trends-to-date

    2018’s Top Clinical Pharma/Bio Trends to Date

    Economic, technological, policy and scientific changes occur so frequently in the hypercompetitive pharmaceutical and biologics sectors that only the most versatile and far-sighted companies can thrive. Get the inside scoop on the top five clinical trends experts believe will be the difference between success or failure for pharma/bio organizations.

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  • 2018-bl-thumb-force-for-change

    A Force for Change: Millennials

    A look at how the changing makeup of the clinical research workforce, with particular attention to the millenial generation, may present future adjustments and opportunities.

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  • 2017-bl-thumb-5-guidelines-for-writing-a-useful-clinical-monitoring-report

    5 Guidelines for Writing a Useful Clinical Monitoring Report

    A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection. Here are a few important guidelines you and your staff should follow to ensure your clinical monitoring reports are accurate and complete.

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  • The Data Driven Reality of Clinical Trials

    Why are metrics important in starting clinical trials? This question may seem counter intuitive, as we are exposed almost daily to the dire performance of clinical trials and their spiraling costs resulting from incurred delays.

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  • CLIA vs QSR (What You Don’t Know Can Hurt You)

    Many industries including automotive manufacturers, NASA, information technology systems, and countless others suggest or even require implementation of a Quality Management System (QMS) in order to ensure products are manufactured to a high quality standard. For products like medical devices, QM systems ensure that products are not only of a high quality, or deemed “effective” to perform as they are intended, but are also safe for their intended use. For all laboratory testing, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), in 1988, which established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. The Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.

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