Sponsors of clinical trials can now easily perform an independent check of the data quality coming in from sites at any time, contribute to a risk-based approach to monitoring and check follow-up by monitors of identified corrective actions.
CHAPEL HILL, NC- Jun 20, 2017 – CROS NT, a global Clinical Research Organization (CRO), today announced CROScheck™, a clinical trial solution to deliver Sponsors the biometrics oversight needed to assess data integrity from multiple sites. By incorporating data management and statistical methodology along with technology, Sponsors can take a modular or full risk-based approach.
DIA attendees are encouraged to visit CROS NT at DIA Booth #1040 to learn more about how CROScheck™ addresses the challenges that Sponsors encounter within the new GCP E6(R2) Guidelines that have recently come into effect. This is especially important as the guidelines state that the ultimate responsibility for the quality and integrity of the trial data will always reside with the Sponsor even if fully outsourced to a CRO.
“CROScheck™ brings together leading edge intellectual property, powerful technology and world class expertise to service a growing need across our customer base. It gives Sponsors the necessary oversight and confidence to meet global regulatory requirements,” said Andrew MacGarvey, CEO of CROS NT. “Central monitoring is increasingly becoming a critical component of clinical studies. CROScheck™ will allow our customers to focus resources and budget in the most effective way,” he added.
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ABOUT CROS NT
Founded in 1992, CROS NT is a data-driven Contract Research Organization (CRO) providing services from feasibility to clinical study reporting for Phases I-IV and medical device trials. CROS NT’s services include regulatory consultancy, monitoring, data management, biostatistics programming & analysis, pharmacovigilance and medical writing — and accompanying eClinical applications (data visualization, EDC, IWRS, eCOA/ePRO etc.). All services are underpinned by strong clinical and biometrics project management with offices located in Europe, the USA and India.