Veeva Systems Case Studies Excelya's Implementation of Veeva Vault eTMF for Enhanced Inspection Readiness

Edit This Case Study Record

	Excelya's Implementation of Veeva Vault eTMF for Enhanced Inspection Readiness Veeva Systems

Excelya's Implementation of Veeva Vault eTMF for Enhanced Inspection Readiness

Veeva Systems

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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.

About 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.

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.

Impact #1	The implementation of Veeva Vault eTMF has significantly optimized Excelya's efforts towards achieving inspection readiness. The solution not only enables real-time data visibility and full-time control, but it also provides the flexibility of software and a personalized approach that CROs need to support sponsors. The Excelya team handles all the tasks that full-time employees would complete, including configuration, validation, and implementation. For larger life science sponsors who want to implement Vault eTMF in-house, Excelya provides multiple models for eTMF services and can also create a tailor-made solution and human resource model for outsourcing sponsor-owned TMF management. The partnership with Veeva has also ensured that Excelya has a responsive software development team to support them, enhancing inspection readiness and improving efficiency.

Impact #1

The implementation of Veeva Vault eTMF has significantly optimized Excelya's efforts towards achieving inspection readiness. The solution not only enables real-time data visibility and full-time control, but it also provides the flexibility of software and a personalized approach that CROs need to support sponsors. The Excelya team handles all the tasks that full-time employees would complete, including configuration, validation, and implementation. For larger life science sponsors who want to implement Vault eTMF in-house, Excelya provides multiple models for eTMF services and can also create a tailor-made solution and human resource model for outsourcing sponsor-owned TMF management. The partnership with Veeva has also ensured that Excelya has a responsive software development team to support them, enhancing inspection readiness and improving efficiency.

Benefit #1	50% reduction in critical data conformance issues with FDA submissions
Benefit #2	Real-time access to TMF data, enabling rapid and real-time access to reports and KPIs
Benefit #3	Reduction in costs due to accelerated activities and frequent quality checks to ensure the completeness of the eTMF

Benefit #1

50% reduction in critical data conformance issues with FDA submissions

Benefit #2

Real-time access to TMF data, enabling rapid and real-time access to reports and KPIs

Benefit #3

Reduction in costs due to accelerated activities and frequent quality checks to ensure the completeness of the eTMF

Download PDF Version

Overview

Excelya's Implementation of Veeva Vault eTMF for Enhanced Inspection Readiness

Operational Impact

Quantitative Benefit