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

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Many clinical trial teams still rely on a legacy TMF – whether that means physical binders or outdated digital folders lacking structure and traceability.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 […]

We Are Hiring: Scrum Master

📍Remote 💼Full-Time Flex Databases is driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with our own offices located in the Czech Republic, Switzerland, Turkey, and the […]

June 12, 2025
The Power of Unified eClinical Platforms: How All-in-One Solutions with API Integration Are Transforming Clinical Trials

Inside the Toolbox: eTMF, CTMS, PV, and EDC Running clinical trials today involves more than collecting data or monitoring patient visits. It’s about keeping everything connected, compliant, and on schedule while managing growing complexity. That’s where unified eClinical platforms come in, and at the core of these systems are several essential modules: eTMF, CTMS, PV, […]

June 5, 2025
We Are Hiring: System Analyst

We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with our own offices located in the Czech Republic, Switzerland, Turkey, and the US.  Key responsibilities: […]

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.