“Data quality issues in clinical trials are an important topic in the biopharmaceutical industry and clinical trials in particular and result from a variety of behaviours including misconduct, intentional or unintentional noncompliance, and significant carelessness. Regulators depend on the validity of study results to evaluate products for marketing approval”

“Several risk-based methods such as targeted on-site monitoring, central monitoring, and statistical monitoring can assist with detecting these threats to data quality. Although an array of detection methods can be employed, the approach should be tailored to the characteristics of the study to ensure targeted analyses and to reduce the manual burden on those overseeing data quality.”

CluePoints is committed to helping sponsors execute clinical trials in line with recommendations set out in the applicable guidance documents. Our products utilize statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data, both during and after study conduct. Aligned with guidance in TransCelerate’s paper, CluePoints is deployed to support traditional monitoring and data management and can be implemented as the ultimate engine to drive RBx – Risk-Based Study Execution.

Check out TransCelerate’s paper (to the right), to discover how the CluePoints platform can help your organization work in line with monitoring recommendations. Alternatively, contact us for a personalized demo.

TransCelerate’s Guidance Paper