Gouya Insights selected Flex Databases eTMF

CDISC is introducing TMF Standard Model V1, the next evolution of the widely used TMF Reference Model. This is more than a new version – it represents a shift toward standardized, digitally managed clinical trial records. What’s changing? When will it happen? Community review of the draft is scheduled to begin this autumn, with the […]

When vendors build tools to evaluate TMF health, they usually focus on three main KPIs: completeness,  timeliness and quality.  These metrics are obviously important, but are they enough?  A real TMF user will go further and ask the next question:  How long did it take the document to move through each of these stages?  The […]

As an EDC Data Solution Specialist (Data Manager), you will work at the intersection of data, systems, and clinical research. You will translate clinical study requirements into practical EDC solutions – from understanding study protocols to building and testing electronic forms, configuring validation rules, and supporting clinical data throughout the study lifecycle. We are looking […]

About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization (CRO) specializing in multi-country clinical trials. As ITS expanded its sponsor portfolio and study volumes, it demanded a document management infrastructure capable of keeping pace – one that could ensure regulatory compliance, support sponsor oversight, and maintain operational control across a growing […]