Immutep Partners with Flex Databases to Digitize Clinical Trial Documentation

March 10, 2026

Prague, Czech Republic – Flex Databases is pleased to announce that Immutep GmbH has implemented Flex Databases eTMF to enhance the management of its Trial Master File (TMF) documentation across ongoing clinical studies. This move underscores Immutep’s commitment to improving efficiency, compliance, and collaboration in clinical trial operations.

We spoke with Tom Apelt, IT Manager at Immutep GmbH, to understand the rationale behind their selection of Flex Databases.

Before adopting Flex Databases eTMF, Immutep relied heavily on a paper-based TMF system, which often caused bottlenecks and limited visibility into document status.

“Managing a physical TMF meant we rarely had real-time insight into missing or expired documents,” said Tom Apelt. “Audit readiness required significant manual effort, which added stress to our teams.”

Immutep’s selection criteria focused on regulatory compliance and cost transparency. The eTMF solution needed to comply with 21 CFR Part 11 and the DIA TMF Reference Model, while providing predictable long-term costs for storage and archiving.

“Flex Databases offered a robust system with clear pricing, which gave us confidence in both compliance and financial planning,” Apelt noted.

The transition to a digital TMF required careful planning and internal coordination.

“Onboarding was smooth, and the vendor team provided excellent support,” Apelt explained. “Nonetheless, integrating the system into daily workflows took longer than we initially anticipated, given the shift from our previous manual processes.”

Since implementation, Flex Databases eTMF has streamlined document management, enhanced audit and quality control workflows, and improved collaboration with external partners such as CROs.

“Role-based access allows our CRO partners to securely collaborate while enabling effective sponsor oversight,” Apelt added.

For organizations evaluating eTMF solutions, Apelt advises prioritizing scalability, comprehensive access controls, audit trail integrity, and robust export functionality.

Flex Databases remains dedicated to supporting sponsors, CROs, and research organizations with scalable eClinical solutions that optimize TMF management, compliance, and operational efficiency.

Contacts:
Email: contact@flexdatabases.com
Phone: +420 296 399 366

About Flex Databases
Flex Databases provides integrated eClinical software solutions to enhance clinical trial oversight, streamline document management, and ensure regulatory compliance.

About Immutep GmbH
Immutep GmbH is a biopharmaceutical company advancing innovative immunotherapy treatments while prioritizing efficient and compliant clinical research operations.

Website: www.flexdatabases.com