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Building a Stronger Foundation for Trial Documentation: How Pharmalys Redesigned TMF Management with Trial Interactive

Pharmalys TI

The Challenge

As trials grew in scale and complexity, so did the demands on Pharmalys’ trial documentation practices. Teams working across multiple geographies and functions needed a single, reliable source of truth for Trial Master File content, one that could keep pace with global collaboration, support consistent filing standards across studies, and stand up to regulatory scrutiny at a moment's notice.

Legacy document management approaches made it difficult to maintain real-time visibility into TMF completeness and quality. Oversight was harder to demonstrate, cross-functional collaboration with external partners was slower than it needed to be, and audit preparation required significant manual effort. Pharmalys needed a technology partner that could support not only a system migration but a genuine transformation in how the organization managed trial documentation, with compliance, transparency, and inspection readiness built in from the start.

The Solution

Pharmalys selected Trial Interactive as its eTMF partner following a structured vendor evaluation process, choosing a platform capable of supporting current operations while scaling with the organization's future growth.
The implementation was designed as a true partnership rather than a simple software rollout. Working closely with Pharmalys' Clinical Operations, Quality Assurance, and IT teams, Trial Interactive supported:

  • Standardized filing and process design, helping Pharmalys align document structures, naming conventions, and quality control processes across studies and teams.

  • Rigorous user acceptance testing, collaborating on comprehensive test scripts covering document upload, indexing, workflow, access controls, and reporting, validated against real-life study scenarios before go-live.

  • A controlled, coordinated go-live, minimizing disruption to ongoing trial activity through close coordination between Trial Interactive and Pharmalys teams.

  • Training and change management support, equipping users across the organization with the practical knowledge and confidence to adopt the platform, backed by guidance materials and ongoing support.

The Impact

Throughout the engagement, the Trial Interactive team worked as an extension of Pharmalys' own project team, resolving issues identified in testing and ensuring the platform was configured to meet both operational needs and regulatory expectations from day one.

With Trial Interactive's eTMF platform now embedded across its clinical trial operations, Pharmalys has achieved:
•    Stronger compliance and inspection readiness, with documentation maintained in a structured, consistent format that supports regulatory expectations and faster audit preparation.
•    Greater operational efficiency, as automated workflows and standardized processes reduce the administrative burden on study teams.
•    Improved global collaboration, giving teams and external partners real-time access to trial documentation regardless of location.
•    Enhanced oversight, with dashboards and reporting tools providing clear, ongoing visibility into TMF completeness and quality across every study.

The successful rollout has given Pharmalys a scalable foundation for document management, built to support the organization as its studies continue to grow in scale and complexity while reinforcing the quality and integrity of its clinical research operations worldwide.