Did you miss our recent webinar on Quality Digitalization? The recording is now available! In this insightful session, Anna Petrovskaya, QA Director at Flex Databases, and Vera Valesova, PhD, Senior Manager at Deloitte, explore the critical aspects of transforming your QMS into a digital solution. Key topics covered: Watch the full webinar and gain valuable […]
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?
And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch.
Periodic TMF reviews automatically documented. Quality and completeness under control!
Flex Databases offers a solution for all your archiving needs.
Late November we’ve hosted a joint webinar with Deloitte on how you can and why you should consider digitalizing Quality Management System.
What’s usually been a whole collection of different graphs is now in one – and you can see when and if something goes wrong.
Flex Databases DMS is done exactly right – and here’s a quick overview of manager & user processes, that get simply better with its implementation.
WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management.