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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.
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Need to further consolidate TMF activities implementing a centralized TMF platform, following transfer from the CRO and establishing a validated and compliant archiving solution for Phase I study data.
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Need for enhancing SOP standardization and reinforcing a TMF‑first approach to help ensure consistent quality standards and sustain a high level of inspection readiness.
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.
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TMF best practice and process consulting
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Organization-wide TMF training and workshops
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SOP development and TMF framework enhancement
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TMF migration and consolidation
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End-of-study TMF quality reviews
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Centralized archiving with Trial Interactive
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.
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Improved TMF quality and completeness, driven by standardized processes and clearer ownership
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Stronger inspection readiness culture, embedded across functions through training and governance
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Reduced regulatory risk, with legacy Phase I studies now centralized, organized, and audit-ready
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Enhanced visibility and control, enabling more confident quality oversight of TMF health