DIA 49th Annual Meeting in Boston, USA, 23-27 June 2013

When preparing a tender for a Clinical Trial Management System (CTMS) and an electronic Trial Master File (eTMF), CROs must choose solutions that meet sponsor expectations and improve operational efficiency while keeping studies inspection-ready. The right choice affects study delivery, compliance, and client satisfaction. Below are the key factors CROs should consider. Regulatory Compliance and […]

How Flex Databases connects your study ecosystem – reliably, securely, and at scale.  Why integrations matter to sponsors and CROs  Integration means that data entered once in a system of record is propagated automatically wherever it is needed. For clinical operations teams this translates into:  Core integration patterns we see most often  1) EDC → […]

In July 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/1466, amending Regulation (EU) No 520/2012. The changes aim to strengthen pharmacovigilance, reduce unnecessary administrative burden, and align EU requirements with global best practices. Most provisions apply from 12 February 2026, with certain Eudravigilance updates taking effect in August 2025. Why the Changes Were […]

A Comparative Look at Europe vs. US Markets  In clinical operations, time is money – but how much money can technology really save you? We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, […]