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Case Study
Vesper Bio Streamlines TMF Archiving with Trial Interactive
About Vesper Bio
Vesper Bio is a clinical-stage biotech company based in Copenhagen, Denmark, developing novel oral therapies for neurodegenerative and neuropsychiatric diseases. The company's lead program centers on VES001, a first-in-class sortilin inhibitor being studied in frontotemporal dementia caused by mutations in the progranulin gene (FTD-GRN).
Vesper Bio was recently named by Labiotech.eu as one of the leading biotech companies in Denmark, reflecting its growing profile in life sciences innovation in the Nordics.
The Challenge
As Vesper Bio closed out its Phase 1b/2a clinical trial, the TMF was hosted within its study service provider’s eTMF platform. According to EMA archiving guidelines, sponsors must ensure their TMF is maintained in a secure, controlled, compliant environment throughout the life of a trial and for at least 25 years after its conclusion. Vesper Bio needed a solution to migrate and archive the TMF while maintaining direct ownership and oversight of its trial documentation.
The Solution
The Trial Interactive team worked closely with Vesper Bio to migrate its complete TMF from the source eTMF into Trial Interactive's TMF Archiving solution, preserving full metadata integrity and the complete audit trail for every document throughout the transition. Trial Interactive’s TMF Services team also reconciled sponsor-level documents into the same TMF environment, ensuring a fully compliant, accessible, and inspection-ready TMF.
The Impact
- A compliant TMF for long-term archiving
- Full metadata integrity and audit trails preserved for every document throughout the migration
- Easy, self-directed access to locate and retrieve specific TMF records, reducing risk and strengthening inspection readiness
- A stronger foundation for future partnerships and ongoing clinical compliance