By Kristin Mauri, Global Head Risk-Based Monitoring, Bioclinica
Regulators are encouraging the industry to take a new quality risk management (QRM) approach to clinical trial execution. The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 R2 guidelines represent the first update to the guidelines in over 19 years. As part of these updates, recommendations on ensuring quality management in clinical trials are at the forefront of this addendum. As companies start to review and interpret these draft guidelines before they are finalized, they are looking not only to reduce their clinical development risk but also to ensure their data quality is such that it continues to meet the standards expected by regulators. To reduce their risk, companies are paying increasingly more attention to risk management practices and are using risk-based monitoring approaches, or RBM, (including central monitoring) to support their compliance with regulations. Moving forward, additional methods to be proactive in their approach to quality management, including expansion of risk reduction, will be expected and possibly required.