Conducting remote bioanalytical data monitoring and review based on scientific quality objectives

Abstract

For bioanalytical laboratories that follow GLP regulations and generate data for new drug filing, ensuring quality standards set by regulatory guidance is a fundamental expectation. Numerous guidelines and White Papers have been published by regulatory agencies, professional working groups and field experts in the past two decades, and have significantly improved the standards of good practices for bioanalysis. From a sponsor’s perspective, continuous quality monitoring of the data generated by CRO laboratories, identifying adverse trends and taking corrective and preventative actions against issues encountered, are critical aspects of effective bioanalytical outsourcing management. This is especially important for clinical bioanalysis, where one validated assay is applied for analyzing a large number of samples of diverse demographics and disease states. This perspective article presents thoughts toward remote data monitoring and its merits for scientific quality oversight, and introduces a novel Bioanalytical Data Review software that was custom-developed and platform-neural, to conduct remote data monitoring on raw or processed LC–MS/MS data from CROs. Flexible, adaptive and user-customizable queries are applied for conducting project-, batch- and sample-level data review based on scientific quality performance factors commonly assessed for good bioanalytical practice.