Inspection readiness is a goal for all CROs and one that Petek Berker Birik, director and head of the eTMF unit at Excelya, works with customers to achieve. Excelya is a pan-European CRO that offers sponsors a personalized approach, high-quality service, and strong clinical expertise.
Petek recently sat down with Pinar Bérénice Bénet, senior director of strategy for clinical operations at Veeva, to discuss how Veeva Vault eTMF is helping Excelya to ensure real-time inspection readiness and full transparency into the progress of a sponsor’s Trial Master File (TMF).
What challenges do emerging biotech companies face around document control and inspection readiness?
One of the biggest challenges is to build and maintain an electronic trial master file (eTMF) that is complete and accurate. Without that, these companies will likely experience delays in market approvals. Unfortunately, it’s common to see issues with FDA submissions—50% end up with critical data conformance issues. There are several potential pitfalls. Some of the most common quality findings of the Medicines & Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) are that data is incomplete, inconsistent, inaccurate, duplicated, misnamed, or misfiled.
Are you seeing any changes in fully outsourced sponsors’ ability to achieve inspection readiness?
Irrespective of outsourcing, biotech and pharmaceutical companies are moving toward a new digital model for document control. Sponsors in an outsourced model must have full visibility, as this is the only way to enable inspection readiness in today’s data-driven world.
The International Coalition of Medicines Regulatory Authorities (ICMRA) highlighted that during the pandemic, hybrid inspections were an important mechanism for balancing regulatory oversight against the risks of individual exposure to COVID-19.
CROs and their staff need to identify and bring on board the right technology to support this new model, but it can prove a steep learning curve for most companies. Not only do they have to understand the full capabilities of the technology, but they also need to either hire new staff to implement it or re-assign existing staff. Those that succeed in putting in place a digital model find their data is easily accessible and complete—giving them a single source of truth for inspection readiness.
What are some must-have capabilities for sponsors and CROs?
You need to complete frequent quality checks to know your TMF status and any issues. Quality checks are most effective when they provide a snapshot of your current position, so the exercise is only helpful if you have real-time access to TMF data. This means access to data anytime, anywhere in the world. When information is up-to-date, teams—remote or on-site—can identify and remediate any inconsistencies or discrepancies in the process, and reporting, ahead of the actual inspection.
How do you help your sponsor customers get inspection ready?
In partnership with Veeva, the Excelya eTMF unit helps customers with the deployment of their eTMF. This allows us 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. We operate with our customers 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 our customers need and the people who can leverage that technology to achieve inspection readiness.
We’ve also found that many sponsor customers do not have the staff or process in place to monitor and manage the eTMF. We can bridge that gap with validated standard operating procedures (SOPs) and specialized resourcing to complement sponsor teams.
How does Vault eTMF optimize sponsors’ efforts?
We benefit hugely from Vault eTMF. 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. With Vault eTMF, our customers see a reduction in costs because we can accelerate activities, including granting rapid and real-time access to reports, KPIs, and implementing frequent quality checks to ensure the completeness of the eTMF. We can also create synergies for the same tasks or within study programs across therapeutic areas. This reduces study delays.
For larger life science sponsors who want to implement Vault eTMF in-house, we provide multiple models for eTMF services and can also create a tailor-made solution and human resource model for outsourcing sponsor-owned TMF management.
How can teams get started with an eTMF solution?
First, choose technology from vendors that maintain best-in-class security measures. Make sure to partner with a responsive software development team. Generally, the research teams working with eTMF software have limited experience with technology, so they are looking for more coaching and explanation as they work through issues or use new capabilities.
Each time we reach out to Veeva, they take the time to listen to the issue, describe the remediation, or walk us through new capabilities in a way we can understand so that we can implement new industry-leading capabilities to enhance inspection readiness and improve efficiency. This gives me confidence that if a customer raises an issue, I’ll be able to work with the Veeva team to find a solution for our sponsors. The Veeva team is available anywhere, anytime, which is a real differentiator for me and us, as a CRO, at Excelya.
“We benefit hugely from Vault eTMF. 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.” Petek Berker Birik, Director, Head of eTMF Unit, Excelya