Don’t Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise

Whether the focus is endpoint adjudication, aggregate data monitoring or safety assessment, the clinical and device development industry clearly understands the value of establishing expert scientific committees to provide oversight on study data. These expert committee assessments provide validation on clinical data as additional support for regulatory submissions and commercial strategy. What is less well […]

New Normal or Not, Safety Reporting Matters

Even during normal times, the usual approach to safety reporting places a heavy burden on sites. Sponsors inundate them with safety notifications, many of which are unnecessary. As a result, sites become overwhelmed and miss critical patient safety information, which become lost in a mountain of paperwork that includes unnecessary notices. Moreover, this practice is […]

People, Process and Technology: The Right Combination for Successful Expert Committees

    About this Episode: Independent expert committees provide essential validation of clinical data. Without their insights, sponsors risk missed signals, conflicts of interest and costly delays. But establishing a successful expert committee can be tricky. It requires the right combination of people, process and technology. In this three-part podcast, Lakshmi Sundar, head of business […]

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