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    • Risk-Based Monitoring: Increasing Efficiency in Cancer Clinical Trials

    • RBM Contributions to Oncology ResearchIt’s Breast Cancer Awareness Month and - in the U.S. - everything from landmark buildings to NFL players are wrapped in pink, to raise both awareness and funding for research.With the American Cancer Society estimating 1.68 million new cases of all cancers this year in the U.S. alone, it’s no wonder the federal government initiated the Cancer Moonshot 2020. That $1 billion effort seeks to “win the war on cancer” by unleashing the potential of combination immunotherapies to treat cancer patients.The National Cancer Institute reports ...
    • Risk-Based Monitoring: Separating the Risk from the Noise

    • Clinical development professionals are tasked with making sure every trial site runs efficiently, follows protocol and generates the highest quality data. With increasing clinical trial length and cost, Risk-Based Monitoring (RBM) is growing exponentially amongst sponsors and CROs.In fact, regulatory agencies are now strongly recommending a risk-based approach to monitoring – encouraging sponsors & CROs to focus resources on sites that need the most monitoring. The FDA has issued guidance (Guidance for Industry Oversight of Clinical Investigations — A ...
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