DATA AND SAFETY MONITORING BOARDS

Federal regulations require appropriate provisions to be in place in order to adequately monitor the data collected and ensure the safety of research subjects. K3-Innovations provides an independent panel of experts who periodically review clinical trial data to ensure integrity, scientific rigor, and patient safety in clinical studies. Ensuring patient safety and clinical trial integrity throughout the independent evaluation of interim clinical trial data is of critical importance for increasingly complex drug development programs.
 

From phase II-III we have highly motivated and vigilant experts who will review and evaluate all of the accumulated study data regarding safety, progress, and efficacy in order to address any major concern, or stop a trial, prior to implementation. This allows for the evaluation of safety, validity, and integrity of the trial. “Making data speak” is our motto and an integral part of clinical trials, but human safety is also our priority. DSMB ensures that both are vigilantly reviewed and evaluated.

We provide comprehensive data and safety monitoring services that are compliant with NIH and DSMB guidelines, such as:

  • Data presentation

  • Member participation

  • Stopping procedures

  • Charter development

  • Interim efficacy analysis

  • Meeting report preparation

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Get in touch with us today and let us know how we can help you