eTMF Inspection Readiness: What Sponsors & CROs Need to Know | Webinar Flex Databases

What does it actually mean for an eTMF to be inspection-ready and who is responsible for making sure it is? In this webinar, “Beyond the Binder: Inspection Readiness in the eTMF Era,” experts from Flex Databases and Forschungsdock CRO GmbH discuss how Sponsors and CROs can approach eTMF inspection readiness before, during, and after an inspection. Speakers: 🎙️ Anna Petrovskaya — QA Director at Flex Databases 🎙️ Christoph Ortland — CEO of Forschungsdock CRO GmbH In this webinar, you'll learn: ✔ What inspection readiness actually means ✔ Why inspection readiness isn't only the Sponsor's responsibility ✔ How Sponsors and CROs should prepare their eTMF for an inspection ✔ What to expect when it comes to eTMF content ✔ What to consider around system validation and access ✔ How to handle the inspection process while maintaining credibility ✔ What to do when inspection findings arise Inspection readiness doesn't start when the inspector walks in. Maintaining a prepared eTMF requires Sponsors and CROs to understand their responsibilities, their documentation, and the systems supporting the Trial Master File well before an inspection begins. Watch the full webinar to hear practical perspectives on preparing for eTMF inspections and navigating the process when an inspection actually happens. About Flex Databases Flex Databases is a unified eClinical platform designed for pharma, biotech, medical device companies, sponsors and CROs of all sizes. The system offers a full range of modules, including CTMS, EDC, eTMF, Pharmacovigilance, and more to cover every aspect of clinical trials and beyond. Whether you're running a single study or managing a global pipeline, Flex Databases provides an all-in-one solution to streamline operations, ensure compliance, and scale with your needs. With over 15 years of experience and 100+ clients across North America, Europe, and Asia, Flex Databases is a trusted partner for clinical trial teams worldwide. #eTMF #InspectionReadiness #ClinicalTrials #TMF #ClinicalResearch #ClinicalOperations #QualityAssurance #FlexDatabases