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risk-based monitoring

This page shows the latest risk-based monitoring news and features for those working in and with pharma, biotech and healthcare.

Gottlieb admonishes industry for clinical trial failings

Gottlieb admonishes industry for clinical trial failings

example based on clinical laboratory, genomic, and proteomic factors, which could reduce the scale and duration of trials. ... The second guidance is a question and answer document on risk-based monitoring (RBM) of clinical investigations that

Latest news

  • Less is more: how risk-based monitoring is changing trials Less is more: how risk-based monitoring is changing trials

    approval on risk-based monitoring (RBM) and has encouraged pharma companies and contract research organisations to start building it into trial designs. ... The last couple of years has seen increased adoption of risk-based monitoring.

  • Harnessing clinical data Harnessing clinical data

    TransCelerate's initiatives  . Risk-based monitoring. Shared site qualification and training. Shared investigator platform. ... use of real-time, risk-based monitoring (RBM) of investigator sites.

  • Taking contract research’s pulse Taking contract research’s pulse

    The biggest change in the operating environment for clinical CROs this year was arguably final FDA guidance on risk-based monitoring to improve patient protection in trials . ... We're seeing a lot of interest in risk-based monitoring,” said Cutler,

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Latest Intelligence

  • Avoiding data pitfalls in clinical research Avoiding data pitfalls in clinical research

    As the volume and variety of data increases, clinical research will require new approaches to automate monitoring. ... Traditional source document verification, for example, is already ceding to risk-based monitoring approaches.

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