BIOTRONIK Selects Flex Databases as a Major System to Cover Clinical Trial Related Activities
November 18, 2025
BIOTRONIK, a leading global medical device company, has selected Flex Databases as its trusted eClinical partner to streamline and enhance the management of its clinical trial operations through Flex Databases’ unified platform.
Comprehensive Functionality and Strong ROI
Following a rigorous evaluation process, BIOTRONIK chose Flex Databases for its broad functionality, competitive pricing, and exceptional return on investment.
“Flex Databases offers broad functionality at a reasonable price,” said Dr. Michael Kraus, Director Clinical Operations & Systems at BIOTRONIK. “There are solutions that offer more but at a significantly higher cost, and others that cost less but don’t meet our needs. For us, Flex Databases delivers the best return on investment.”
Transforming Clinical Trial Operations
Transitioning from a custom-built internal system, BIOTRONIK anticipates significant benefits from adopting the Flex Databases suite:
• Reduced maintenance workload for internal IT teams.
• Simplified validation and adaptation processes for regulatory changes.
• Access to state-of-the-art interfaces and reporting, improving operational transparency and oversight.
A Partnership Built on Collaboration
As the previous BIOTRONIK in-house system was very specific to BIOTRONIK’s internal processes, learning to transition to a SaaS model took time. Flex Databases was supportive and repeatedly demonstrated how their system could flexibly accommodate BIOTRONIK’s needs.
Unified Platform: All Modules, One Vision
BIOTRONIK was particularly interested in the integration of key modules – eTMF, CTMS, PM & Budgeting, and QMS – within a single ecosystem.
Flex Databases offers these key modules combined in one suite and provides a compelling solution, also including the Payments & Budgeting tool, which aligns closely with BIOTRONIK’s processes and existing workflows.
Looking Ahead: A Strategic Partnership
Selecting an all-in-one enterprise solution was a mandatory requirement for BIOTRONIK’s RFI process, ensuring scalability for its global operations.
BIOTRONIK expects a highly engaged and responsive partner which helps to set up the system efficiently, train the teams thoroughly, and continue improving the solution with combined expertise.
About BIOTRONIK
For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology.
From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia – bringing bold, future-ready solutions that are shaping the next generation of medical technology.
