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Case Study
Building Clinical Documentation Excellence: How iOnctura Centralized and Strengthened Its TMF
The Challenge
iOnctura is a growing clinical-stage biopharmaceutical company headquartered in Geneva, Switzerland, focused on developing precision therapies for hard-to-treat cancers. With a diverse pipeline spanning Phase I and Phase II studies across solid and hematological tumors, the company was entering a critical stage of clinical development.
As clinical activity expanded and inspection readiness expectations increased, establishing a robust and scalable approach to trial master file (TMF) management became a priority. This presented new needs.
The Solution
Trial Interactive partnered with iOnctura to implement a phased approach combining consulting, training, and technology. The engagement began with organization-wide TMF workshops, aligning teams on GCP expectations, quality standards, and industry best practices—explaining the need for further investing in a shared compliance mindset.
This was followed by a comprehensive review of TMF plans and SOPs, identifying gaps and strengthening governance frameworks to support long-term scalability. In parallel, legacy Phase I studies were migrated into a centralized, compliant environment, supported by end-of-study TMF quality reviews. This culminated in the implementation of Trial Interactive Archiving as a secure, long-term repository for clinical documentation.
The Impact
The partnership enabled iOnctura to transition to a structured, inspection-ready TMF model following transfer from the CRO. Today, iOnctura operates with a scalable TMF framework, supported by the right technology and a partner aligned with its continued clinical growth.