iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials

February 8, 2023

iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials

We’re excited to announce a new client – a US-based biotech iRenix Medical. Earlier this year, iRenix team selected Flex Databases as an eTMF provider.

We’ve asked Stephen J. Smith, MD, Founder and CEO at iRenix Medical a couple of questions about the upcoming partnership:

Why iRenix Medical decided to implement eTMF module? What was the starting point for digitalization?

iRenix is committed to improving ophthalmic patient care. A key part of achieving this mission is completing high quality clinical trials that can be used to support FDA registration of key products in development. Using an eTMF allows us to achieve compliance with key regulations while also supporting multi-center clinical trials. 

Why did you select Flex Databases to be your software provider?

iRenix selected Flex Databases after a thorough review of their system and comparison to competitors. The reviews and demos made us comfortable that this system offered key functionality in an easy-to-use interface for our staff and clinical trial sites. 

What do you expect to achieve with the implementation of Flex Databases?

iRenix expects to have a seamless integration of this system into our clinical trial workflow, with excellent system support throughout the duration of our clinical trials.  

Blog

July 3, 2025
Everest CRO Experience with Flex Databases

Dana Leff Niedzielska, MBA, SVP of Global Clinical Operations at Everest Clinical Research, shares her experience using Flex Databases’ CTMS and eTMF. In this interview, Dana highlights how Flex Databases supports Everest CRO’s clinical operations. Learn why Everest chose Flex Databases as their trusted technology partner and why they continue to rely on and trust […]

July 1, 2025
What’s New This June: Smarter Imports, Cleaner Reports, and More Flexible APIs

Pre-Validation for CRA Reports The Monitoring Activity report tab now features a validation preview. Users can check for missing fields and review validation messages before generating the final report – enabling more accurate submissions and reducing the need for rework. Bulk Imports for Milestones and Assumptions You can now bulk import project milestones and assumptions […]

June 24, 2025
ICH GCP E6(R3) is about to go live in the EU

The countdown is on – ICH GCP E6(R3) is about to go live in the EU, and everyone’s getting prepared! As a service provider (you caught that new R3 definition during training, right?), Flex Databases is here to support you through the transition. Let’s highlight a few areas that are especially important for our clients: […]

June 19, 2025
Checklist: Migrating from a Legacy TMF to an eTMF

Many clinical trial teams still rely on a legacy TMF – whether that means physical binders or outdated digital folders lacking structure and traceability. These systems often fall short in today’s increasingly regulated, fast-paced environment, making oversight and compliance more difficult. That’s why more sponsors and CROs are transitioning to a modern eTMF. A modern […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.