We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the client involvement and requirements.
We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world.
Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.
Clients
Daily users
Documents
Clinical trials
Countries
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 […]
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