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Effective site monitoring requires rigorous follow-up to ensure that all open issues are properly addressed, closed and documented. The task of remembering and tracking action items is daunting not only for the CRA but also for the clinical research coordinator CRC who are both juggling between multiple studies and numerous other trial emergent day-to-day issues.
This further involves on and off communication with clinical sites to confirm not only the completion status but also to verify that the action item is resolved accurately. CTMS system has not only replaced the standard and passive trackers but also comes with enhanced reporting capabilities that dynamically and automatically identify trends and measures site performance to compliance, thus, providing valuable insights to make meaningful operational decisions.
This new age solution can query SMV reports on multi-variable matrices, integrate and normalize all relevant data and extract information, as required. User-friendly visualizations that incorporate charts and graphs simplify the ability to identify trends and measure performance in real-time. Action items that go unresolved may pose a risk to subject safety and data integrity. Smart and efficient CTMS solutions that use strategy, technology, and design to efficiently manage action items can help sponsors not only achieve quality and compliance but also minimize risk and cost at the same time.
Veristat provides a clinical monitoring team that comprises both Veristat employees and trusted contractors, many of whom we have worked with for many years to provide the most effective and flexible solutions for each project. This approach provides our clients with a skilled and qualified therapeutically focused team.
Completing a natural history study in conjunction with an interventional study for Learn how to strategically migrate and produce clinical trial data outputs in submission-ready format to reduce timelines without sacrificing data quality.
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