Webinar: Actionable milestones to connect & control project performance throughout CTMS & eTMF

In October 2024, the U.S. Food and Drug Administration issued a final guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers. https://www.fda.gov/media/166215/download    This guidance provides recommendations on the use of electronic systems, electronic records and electronic signatures in food, medical product, tobacco product, and new animal drug clinical investigations.  […]

We are excited to share that Flex Databases has been named a Top Clinical Management Provider for 2024 by Life Science Review. This prestigious recognition highlights our strong reputation and the trust placed in us by both customers and industry peers, reflected in numerous nominations from Life Science Review subscribers. This award comes at a […]

A regulatory binder is crucial for managing clinical trial documents, it ensures compliance with regulations, and makes audits easier. It helps keep important documents organized and readily accessible for trial monitors, auditors, and regulatory authorities, and serves as a useful reference for the research team. While it’s not legally required, maintaining a regulatory binder is […]

What aspects need validation to ensure confidence in AI-driven processes, and is it possible to achieve 100% certainty?