Faron selected Flex Databases eTMF to have better oversight for Faron sponsored studies

December 6, 2021

Faron selected Flex Databases eTMF to have better oversight for Faron sponsored studies

This summer Flex Databases and Faron, a Finnish biopharmaceutical company, signed a contract for eTMF implementation.

We’ve asked Maria Lahtinen, Director, Supplier Management at Faron, a couple of questions about the new partnership:

Why Faron decided to implement eTMF? What was the starting point for digitalization?

Faron had two aims for the project – to have a Faron-managed TMF system and to have it as an electronic format. The main driver for the system implementation was to have better oversight for Faron sponsored studies. So far, Faron has used the eTMF systems managed by CROs.

Why Faron selected Flex Databases as a software provider?

Faron needed to find a software provider capable to fulfill all different requirements (technical, data security, validation, user experience and co-operation requirements). We also needed a software provider ready to guide us through the set-up and implementation of the system; with a team readily available to answer all manner of questions that arise through the process. We were looking for flexibility because all study-specific requirements were not clear for us when we started the selection process. The time for the set-up was also limited because we wanted to have the system in use very quickly for our upcoming studies but with strictly qualified process.

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

Interactive approach to allow review of study documentation at any point in the lifecycle of each of our studies. We were aiming for better quality management, quicker processes and audit readiness. A key element was the feeling of confidence that we are on track with all activities and that our study is proceeding well, in a compliant way.

Faron is a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system in order to tackle cancer and inflammation. Since its founding in 2007, the company’s goal has been to develop a diverse and unique pipeline rooted in high-quality science and innovation. Faron is focused on mastering immune modulation by harnessing endothelial receptors to control and mediate immune responses.

Blog

August 28, 2025
Integrations in Clinical Trials: An IT/ETL Perspective

How Flex Databases connects your study ecosystem – reliably, securely, and at scale.  Why integrations matter to sponsors and CROs  Integration means that data entered once in a system of record is propagated automatically wherever it is needed. For clinical operations teams this translates into:  Core integration patterns we see most often  1) EDC → […]

August 14, 2025
Key Changes to EU Pharmacovigilance Regulation: What You Need to Know

In July 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/1466, amending Regulation (EU) No 520/2012. The changes aim to strengthen pharmacovigilance, reduce unnecessary administrative burden, and align EU requirements with global best practices. Most provisions apply from 12 February 2026, with certain Eudravigilance updates taking effect in August 2025. Why the Changes Were […]

July 31, 2025
How Much ROI Can You Expect from eTMF and CTMS? 

A Comparative Look at Europe vs. US Markets  In clinical operations, time is money – but how much money can technology really save you? We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, […]

July 29, 2025
The Flex Databases team is looking for a QA Engineer / Tester. 

📍Remote 💼Full-Time Applications for this position are now closed and no longer being reviewed. 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 […]

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.