Epista Launches Major Clinical Data Remediation Program with Global Pharma Leader

King of Prussia, PA, United States, October 13th, 2025

‍

Epista Life Science today announced one of the pharmaceutical industry's most comprehensive clinical data remediation programs, a multi-phase initiative spanning more than 800 studies, 43,000 study sites, and over four million clinical documents. The program will prepare a leading global biopharmaceutical innovator for the successful implementation of a next-generation Clinical Trial Management System (CTMS) while establishing enterprise-wide data governance standards.

The remediation program will deliver three critical outcomes that directly support the client's CTMS migration and long-term operational excellence:

• Enhanced TMF Oversight - Comprehensive reporting and monitoring systems that provide real-time visibility into Trial Master File health, ensuring regulatory compliance and inspection readiness
• CTMS Migration Readiness - Fully remediated, standardized data that guarantees seamless implementation of next-generation clinical trial management systems with zero legacy data issues
• Future-Ready Data Infrastructure - Enterprise-wide governance standards that ensure data quality and consistency, positioning the organization to leverage advanced analytics and AI-driven insights.

The program leverages Epista's proven remediation methodology in partnership with the DNANexus platform, enabling accelerated data quality improvements at unprecedented scale.

‍

"This represents the largest clinical data remediation program Epista has undertaken, and it's solving one of the most critical challenges in clinical operations today," says Toni Lakin-Ritter, Managing Director, Epista Life Science US and continues:

“You cannot successfully implement a modern CTMS on top of inconsistent, unreliable data. This program ensures our client's digital transformation is built on a foundation of trusted, inspection-ready information that will support their operations for years to come.”

The initiative builds on Epista's expanding relationship with the client, where the consultancy has previously supported inspection readiness, TMF completeness, and business continuity during mergers and acquisitions.

The program will include comprehensive data quality assessments, coordinated remediation waves across key clinical domains, and implementation of a sustainable governance framework. A structured hypercare phase will ensure adoption and continuous quality monitoring, delivering both immediate impact and long-term operational value.

“Our vision is to create a data environment that not only supports compliance and operational excellence but also fuels innovation for the future of clinical trials.”

says the client's Director of Clinical Records & Information Management and continues: “With Epista leading this effort, we are confident in achieving better TMF oversight and reporting, a solid foundation for CTMS, and the enterprise-wide governance needed to enable AI-driven insights. This partnership is more than a project — it is a transformation of how we manage and trust our data.”

The remediation program is expected to reduce study startup times, minimize inspection risk, and enable real-time operational insights across the enterprise once the new CTMS is fully implemented.

‍

About Epista Life Science

Epista Life Science is a global consultancy dedicated to defining and delivering process, technology and compliance excellence, thereby enabling Life Science companies to operate better, safer and faster in their ongoing efforts to improve health and well-being around the world.