How we implemented eTMF & developed SOPs in 3 weeks for iRenix

February 22, 2024

How we implemented eTMF & developed SOPs in 3 weeks for iRenix

Last year, right around this time, we implemented an eTMF for a California-based Medical Device company, iRenix. Our target? A swift 3-week completion, so everything was up and running before their FPI. Now, this is quite the sprint compared to the usual 5-6 weeks!

And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch. This wasn’t just about getting a system up and running. We crafted SOPs tailored for them to be included into their Quality Management System – SOP on electronic systems use, validation and eTMF, completed the validation process, and made sure the eTMF was ready to use. Our goal was to have the operations team simply log in and do what they do best in their clinical trials, without the headache of system implementation. They needed to start reaping the benefits ASAP, without being slowed down by the technicalities.

We turned iRenix CEO expectations into reality: “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”.

The system’s not just running; it’s thriving, on time, and with every piece of documentation in tip-top shape, approved, and organized. We’re in the business of making life simpler, not more complicated. We’re here to streamline, boost efficiency, ensure compliance, and yes – save time and money too!

Reach out and let’s chat about how we can make things a whole lot easier for you!

Blog

May 29, 2025
Flex Databases Product Updates: Enhanced TMF, PV, and More

We’re excited to announce a series of updates across several modules of Flex Databases. From enhanced UI navigation to smarter automation and configuration options, these improvements are designed to streamline workflows and boost productivity across clinical operations. Trial Master File (TMF) Redesigned Project Configuration InterfaceWe’ve introduced a UX/UI enhancement to the Project Configuration section (Trial […]

Clinical Trials Trends and Insights in 2025

Clinical trials are evolving fast. In 2025, technology and smarter processes are reshaping how studies are run – making them faster, more efficient, and more patient-friendly. In this article, we’ll explore the trends you can’t afford to ignore: from the growing use of AI to stronger patient engagement, remote trial management, and a renewed focus […]

May 22, 2025
Product Updates: Smarter Planning, Cleaner Data, and Seamless Integration Across Modules

We’re excited to share the latest enhancements across multiple Flex Databases modules, all designed to improve your efficiency, reduce duplication, and support better data consistency throughout your clinical operations. CRA Activity Management: SDV Log Tracker To improve source data verification (SDV) oversight, we’ve introduced a new SDV Log Tracker. This tracker pulls data from Subject […]

May 20, 2025
Clinical trial memes

Clinical research is serious – but a little humor goes a long way. To celebrate International Clinical Trials Day, we’ve created a few memes that only researchers will truly appreciate. Because sometimes, laughter is the best medicine (after rigorous testing, of course).

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.