Customer Case
From Paper-Heavy Workflows to Digital Readiness: an eTMF Implementation in Animal Health
An animal health company worked with NNIT's Veeva team to upgrade its processes, transitioning from paper records to a validated electronic Trial Master File (eTMF) system. The solution improved accuracy, strengthened regulatory compliance, enabled instant access to documents, and made collaboration easier. By supporting the adoption of eTMF technology in animal health drug development, NNIT helped raise the standard for quality documentation and inspection readiness across the full study lifecycle.
Case in brief:
Challenge: Manual filing and paper-based searches delayed animal health trials, increased the risk of lost data, and threatened confidentiality. Limited visibility across global teams further slowed innovation and technology adoption.
Solution: Implementation of a validated and scalable electronic Trial Master File (eTMF) with aligned governance, oversight, and digital workflows.
Benefit: The digital setup reduced documentation errors, strengthened regulatory compliance, enabled faster access to critical documents, improved data security, and supported real-time collaboration across global study teams.
Why move from paper to an eTMF? Paper-based processes were limiting trial efficiency
The company relied on physical documentation to manage its trial master files. This led to:
Manual filing and retrieval that slowed trial progress and created operational inefficiencies.
Incomplete documentation and compliance gaps that posed risks to data integrity and regulatory readiness.
Paper records that were difficult to track, increasing the risk of lost or misplaced sensitive information.
Limited visibility across global teams, which restricted collaboration, slowed innovation, and made it harder to keep veterinary clinical trials progressing efficiently.
Building a sustainable digital foundation for animal health trials
NNIT worked closely with the company to design and execute the transition from paper to digital for animal health research documentation. The project went far beyond technology; it focused on establishing a sustainable way of working for study teams developing veterinary medicinal products. Key strategic initiatives enabling this digital transformation included:
The CDISC TMF Reference Model was tailored to animal health, incorporating relevant terminology.
A governance framework and new SOPs were established to ensure consistent processes.
The eTMF system was configured and validated to provide a reliable, complete, and timely data source.
NNIT also delivered targeted training and change management to support global adoption, and provided flexible ongoing support for clinical operations to manage administration.
"By moving to a validated eTMF, we strengthened compliance, improved collaboration, and gained full visibility across global trial documentation."
Klaudia Markowski, Principal Consultant, NNIT
A Compliant Digital eTMF Built for Long-Term Operational Readiness
By combining deep Veeva eTMF expertise with strong knowledge of life sciences and animal health regulations, NNIT ensured a smooth technical implementation and long-term operational readiness. The partnership enabled a structured transition from paper-heavy workflows to a compliant digital eTMF platform, allowing internal teams to focus on advancing veterinary research rather than managing documentation. The result is a more agile, compliant, and collaborative way of working, one that strengthens regulatory compliance and quality and positions the company to accelerate innovation in the years ahead.
Related Insights & Resources
Explore our expert content to learn more about innovation, compliance, and digital enablement in Clinical operations
Life Sciences, Clinical
Webinar: What Does It Take to Get Digital Biomarkers Right in Clinical Trials?
Life Sciences, Clinical
Digital Biomarkers in Clinical Trials: The Signal Is the Easy Part
Life Sciences, AI, Clinical, Data
GenAI in Pharma: Molecule Discovery Automation with NNIT
Life Sciences, AI, Clinical, Data
Data governance for life sciences - A fast-growing biotech company gained a data foundation built to scale with its growth
Life Sciences, Clinical, Regulatory Affairs
Webinar: Content Governance in the Age of AI: Preparing Pharmaceutical Organisations for ePI and FHIR I by Docuvera & NNIT
Life Sciences, Clinical, Data, Digital Manufacturing, Drug Safety, Regulatory Affairs, Smart supply-chain
How to build a universal translator for pharma data with FHIR
Life Sciences, Clinical
Empowering Decentralized Clinical Trials with Compliant Digital Tools
Life Sciences, Clinical, Data
Data Enablement: Leverage eTMF for business transformation
Life Sciences, Clinical, Microsoft Solutions
Achieve TMF inspection readiness and maintain oversight with AI