Excelya's Implementation of Veeva Vault eTMF for Enhanced Inspection Readiness
Technology Category
- Analytics & Modeling - Real Time Analytics
- Drones - Drone Payloads & Accessories
Applicable Industries
- Education
- Pharmaceuticals
Applicable Functions
- Maintenance
- Quality Assurance
Use Cases
- Infrastructure Inspection
- Security Claims Evaluation
Services
- Testing & Certification
- Training
About The Customer
Excelya is a pan-European Contract Research Organization (CRO) that offers sponsors a personalized approach, high-quality service, and strong clinical expertise. The company works with customers to achieve inspection readiness, a critical goal for all CROs. Excelya's eTMF unit, headed by Petek Berker Birik, partners with Veeva to ensure real-time inspection readiness and full transparency into the progress of a sponsor’s Trial Master File (TMF). Excelya's customers include emerging biotech companies that face significant challenges around document control and inspection readiness.
The Challenge
Emerging biotech companies face significant challenges around document control and inspection readiness. One of the most critical issues is building and maintaining an electronic trial master file (eTMF) that is complete and accurate. Without this, companies are likely to experience delays in market approvals. It is common to see issues with FDA submissions, with 50% ending up with critical data conformance issues. Common quality findings of the Medicines & Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) include data being incomplete, inconsistent, inaccurate, duplicated, misnamed, or misfiled. Furthermore, the shift towards a new digital model for document control presents a steep learning curve for most companies. They need to understand the full capabilities of the technology and either hire new staff to implement it or re-assign existing staff.
The Solution
Excelya, in partnership with Veeva, helps customers with the deployment of their eTMF. This partnership allows Excelya to maintain an eTMF hub that connects a dedicated central reviewer team, trained project leaders, clinical research associates, Vault eTMF specialists, and “superusers” across multiple countries. At the center of this hub is Vault eTMF, which operates under a structured oversight plan, designed according to eTMF KPIs, and under the careful direction of an eTMF unit manager. This model creates harmony between the technology customers need and the people who can leverage that technology to achieve inspection readiness. Excelya also bridges the gap for sponsor customers who do not have the staff or process in place to monitor and manage the eTMF, by providing validated standard operating procedures (SOPs) and specialized resourcing to complement sponsor teams.
Operational Impact
Quantitative Benefit
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