Goodbye Paper, Hello Digital - The TMF Makeover

Through NNIT’s expertise with Veeva solutions, the company transitioned to a fully digital Trial Master File (eTMF). The result? Faster access to critical documents, stronger compliance, and a future-proof foundation for clinical operations.

From paper-heavy workflows to digital readiness

Previously, the organization relied on physical documentation for trial management, which meant manual filing and retrieval processes, risk of incomplete documentation and compliance gaps and limited visibility across global teams.

To address these challenges, the company set out to implement a validated, digital TMF solution that could scale with future research needs while remaining inspection-ready at all times.

Implementing Veeva eTMF with NNIT

NNIT worked side by side with the company to design and execute the transition from paper to digital. The project went far beyond technology - it was about building a sustainable way of working for clinical teams:

• System implementation and validation: Veeva eTMF was configured and validated to meet strict industry and regulatory requirements, ensuring a compliant and inspection-ready environment from day one

• Migration of legacy documents: A tailored migration strategy allowing critical paper records to be digitized and transferred with integrity, ensuring historical trial data was preserved

• Business readiness and adoption: NNIT supported the company with updated SOPs, targeted training, and structured change management so users could quickly adapt to the new system

• Ongoing support model: A flexible support structure was established, providing continuous access to NNIT experts and ensuring the customer’s internal teams could focus on value-adding activities rather than system administration.

Measurable benefits

Since going live with Veeva eTMF, the company has experienced tangible improvements across its clinical operations:

• Improved compliance: Built-in system controls reduce the risk of missing or incomplete documentation, increasing confidence during inspections

• Greater efficiency: Documents are instantly accessible, eliminating delays caused by manual handling and storage

• Enhanced collaboration: Global teams can now work together in real time, regardless of location, creating a unified way of managing trial documentation

• Scalability for growth: The digital platform provides a solid foundation that can easily support future research expansion without adding administrative burden.

How NNIT creates value

By combining deep Veeva expertise with a strong understanding of the life sciences regulatory landscape, NNIT enabled the company to move seamlessly from a paper-heavy environment to a modern digital platform. The partnership ensured not only a smooth technical implementation but also long-term business readiness, allowing internal teams to focus on advancing research rather than managing documentation.

The result is a more agile, compliant, and collaborative way of working - one that positions the company to accelerate innovation in the years ahead.

Reference call available upon request.