Cronos Clinical Consulting Services, Inc. supported blinded third party adjudication reviews of primary endpoint efficacy assessment data. Blinded review of audio-recorded efficacy assessments was performed to confirm results and identify error or deviation from adherence to GCP and best assessment practice. Project specifications included: 5 protocol designs, 300 study sites, 25 countries, 15 languages, data collection for 30,000 unique subject visits, and complex study efficacy entry and protocol rollover criteria.
CIRP automated workflow allowed a site to request an adjudication, and matched the appropriate available resources to conduct a blinded review. The system received data streams from site-based tablets, an IWRS provider, an EDC, and 6 different external vendors, and analyzed it to perform complex calculations to proactively identify and suggest the need for an adjudication (while also allowing the site to raise an issue independently). All adjudication results were pooled and further analyzed (applying methods of risk-based monitoring) to identify training needs at the individual, site, country, and study level.
Integration of the CIRP system resulted in effective implementation of the adjudication process, allowing errors to be corrected and remediated over the course of the trial, and eliminating the chance for a mistake to propagate and evolve into an undetected trend that may negatively influence the study outcome.
Click here to find out more about CIRP.