AI validation for life sciences – a unique challenge of dynamic nature
What aspects need validation to ensure confidence in AI-driven processes, and is it possible to achieve 100% certainty?
Clinical trials are known for being extremely expensive and complicated, yet some right tools can make things easier – a tool like Flex Databases system, for example. Here’s how:
CTMS:
- Flex Databases CTMS is a single point for management of all clinical trial components, including project management, monitoring activities, sites management, and payments. There’s no need for multiple solutions and providers – everything is in one right place accessible from any device all over the globe.
- Monitoring module of our CTMS provides complete automation of monitoring processes and site health assessment, starting from planning and scheduling site visits to tracking of protocol deviations, action items, issues, etc. With flexible reporting tools and KPIs, we ensure full process transparency and performance control at any stage.
- Site Payments module delivers a significant impact on financial transparency, speed, and simplicity. The results of a user survey at one of our customers – global pharmaceutical company – shows up to 8 times increase in processes speed and up to 3 times decrease of workload.
- Sites are happy and engaged. Enhance your site relationships with quick on-time payments with no delays or errors. Hassle-free payments to sites is an advantage for both sponsors and CROs.
- Sites management module helps to organize all information on investigators, sites, vendors, therapeutic areas, RA/IRB/LEC, etc. It provides easy search capability for feasibility assessments and sites qualification.
- No more multiple systems and spreadsheets to report and reconcile!
- TMF ensures full control of trial documentation in a simple interface. It clearly shows what documents are there and what needs to be done. Everyone in the system is on the same page and knows exactly what has happened and what needs to happen.
- TMF is continuously audit-ready: you can see the situation in real-time mode and provide read-only system access for auditors and inspectors, or export data in a convenient format.
- One place for all files: role-based access control allows to set-up access rights up to folder level.
- Automated quality control workflow inside of the system to review, edit, and approve documents with 21 CFR Part 11 compliant electronic signature.
- When the study is over or whenever the need occurs, the system administrator can create an archive of the project documentation or an archive of the selected folders, including the Audit Trail and Index report.
Interested in any of the products described above? Send us an e-mail to bd@flexdatabases.com or simply request a demo via the form on top of the page.
