BIOTRONIK Selects Flex Databases as Its Global eClinical Partner

BIOTRONIK, a globally recognized leader in medical technology, has chosen Flex Databases to support and enhance the management of its clinical trial operations. The company will adopt Flex Databases’ unified eClinical platform to streamline processes, improve oversight, and support long-term digital transformation.

A Decision Driven by Functionality and ROI

After an extensive evaluation process, BIOTRONIK selected Flex Databases for its broad functionality, competitive pricing, and strong 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.”

Supporting BIOTRONIK’s Operational Shift

The company is transitioning from a highly customized internal system to a modern SaaS environment. Key expected benefits include:

• Reduced reliance on internal IT resources

• Easier validation and regulatory adaptation

• Improved reporting and transparency through advanced interfaces

The shift required adapting long-standing internal processes. According to BIOTRONIK, Flex Databases continuously demonstrated product flexibility and supported the teams throughout the transition.

A Unified Platform to Strengthen Clinical Operations

BIOTRONIK emphasized the need for an integrated approach to eClinical operations. Flex Databases met this requirement by offering a single suite that combines critical modules such as eTMF, CTMS, PM & Budgeting, and QMS.

The platform’s Payments & Budgeting tool also aligned well with BIOTRONIK’s workflows, strengthening the overall value proposition.

A Strategic Partnership for the Future

BIOTRONIK’s RFI process required an enterprise-level, all-in-one solution capable of supporting global operations. With Flex Databases, the company expects a responsive partner committed to efficient implementation, comprehensive training, and continued product evolution.

About BIOTRONIK

For more than 60 years, BIOTRONIK has been a pioneer in medical technology, developing innovative therapies that improve the lives of patients with heart disease and chronic pain. The company’s portfolio spans advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, as well as solutions for Electrophysiology.

From creating Germany’s first pacemaker in 1963 to driving progress in digital technology and Conduction System Pacing, BIOTRONIK continues to raise the standard for quality and innovation. Headquartered in Berlin, the company operates in more than 100 countries across the Americas, EMEA, and Asia.