Strengthening eClinical Data Integrity: Data Monitoring

By Terek Peterson, MBA, Vice President Customer Experience and Data Science

As the use of eCOA expands to incorporate more submission-critical elements, especially key endpoints and factors contributing to per protocol analyses, customized compliance strategies are more important than ever to ensure data integrity. By following ALCOA principles for data integrity, quality assurance processes, system controls and customized approaches can drive completeness, consistency, and accuracy of data throughout the data lifecycle of a clinical trial.

System-level processes and custom functionality can help study teams manage risk of non-compliance through edit checks, data monitoring and predictive modeling.