KING OF PRUSSIA, PA — Epista Life Science has announced the launch of one of the pharmaceutical industry’s largest clinical data remediation programs, a multi-phase initiative covering more than 800 studies, 43,000 sites, and over four million clinical documents. The effort is designed to prepare a global biopharmaceutical company for the rollout of a next-generation Clinical Trial Management System (CTMS) while establishing consistent data governance standards across the enterprise.
The program aims to deliver three primary outcomes: enhanced oversight of Trial Master Files (TMF), complete readiness for CTMS migration, and a future-proof data infrastructure capable of supporting advanced analytics and AI-driven insights.
“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,” said Toni Lakin-Ritter, Managing Director of Epista Life Science US. “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.”
Epista’s methodology, coupled with the DNANexus data platform, will accelerate remediation at scale, ensuring data quality and standardization across the client’s global study portfolio. The initiative builds on a long-standing partnership between Epista and the biopharmaceutical company, following previous collaborations in TMF completeness, inspection readiness, and M&A-related data integration.
The program includes extensive data quality assessments, synchronized remediation waves across critical study domains, and the introduction of a sustainable governance framework. A “hypercare” phase will support adoption and continuous improvement to ensure long-term data integrity.
“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,” said the client’s Director of Clinical Records & Information Management. “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.”
Once completed, the remediation program is expected to streamline study startup processes, reduce inspection risk, and enable real-time operational visibility across the organization—positioning the client for faster, data-driven decision-making in clinical research.
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