eTMF to arrange your Quality Review of Folder Completeness 

Most sponsors associate protocol deviations with events that occur later in a clinical trial, like missed visits or incomplete documentation. In reality, one of the earliest and most consequential protocol deviations is happening during patient randomization. Randomization is often perceived as a simple operational step:patient enrolled, button clicked, treatment assigned. But under the pressure of […]

What Sponsors Should Really Look For When Choosing an eClinical Platform?  Today, every established vendor offers all kinds of system modules, document management capabilities, and a long list of compliance certifications.  On paper, they appear remarkably similar, making it increasingly difficult for sponsors and CROs to distinguish between solutions based on feature lists alone.  In reality, they couldn’t be more different.  Most enterprise eClinical platforms can […]

Every clinical trial role requires different information. CRAs need to track upcoming monitoring visits, Project Managers need study performance metrics, and clinical operations teams need enrollment and site activity data. In this video, see how Flex Databases CTMS allows every user to create a personalized dashboard without affecting other users. Learn how to add or […]

About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization conducting multi-country clinical trials and supporting post-marketing needs across a growing sponsor portfolio. As case volumes increased, so did the complexity of managing pharmacovigilance activities from safety event intake and workflow tracking to regulatory reporting and cross-functional coordination with clinical operations teams. […]