By Clinical Informatics News Staff

April 19, 2018 | Veeva Systems announced that Debiopharm selected Veeva Vault eTMF to improve oversight across its trial master file (TMF) processes and work closely with contract research organizations (CROs) by collaborating on a single, cloud-based application. 

“Veeva is helping us streamline our clinical operations,” said Christian A. Aeschlimann, director of clinical operations at Debiopharm, in a press release. “Veeva Vault eTMF will help us maintain an always-accurate, up-to-date TMF and align with external partners by working in the same system.”

As a sponsor, Debiopharm is required by ICH E6(R2) to maintain oversight throughout clinical trials. External partners were unable to access the company's previous, on-premise eTMF, so CROs used their own systems and transferred documents periodically. This meant that Debiopharm did not have full, real-time visibility into the CROs’ TMF activities.

Veeva Vault eTMF provides a single source of truth for trial documentation. Sponsors and CROs can manage TMF documents and processes in the same system, in real-time, as they are being executed. Now Debiopharm can keep its TMF in a constant state of inspection readiness and ensure partners adhere to its standard operating procedures.

“In our quest for continuous improvement, we selected Veeva Vault eTMF to help us work more efficiently and maintain high-quality trial documentation,” Vincent Demeautis, clinical operations manager at Debiopharm, said in the company press release. “Sharing a single system with CROs to drive all TMF processes will eliminate the need to manage and reconcile multiple TMF sources while improving our responsiveness and collaboration with external and internal study team members.”

Veeva Vault eTMF will also provide Debiopharm with reports and dashboards for visibility into TMF completeness, timeliness, and accuracy. This will help the company to check the status and quality of documentation and proactively resolve any issues that arise.

"Veeva Vault eTMF was the best solution on the market to meet our current and future needs," wrote Sofie Lemmens, senior clinical trial associate at Debiopharm, who led the implementation of Veeva Vault eTMF, in an official statement. "It was a critical investment across our internal teams to improve TMF quality and access."

By adopting Veeva Vault eTMF, Debiopharm has taken its first step toward a unified clinical model to streamline end-to-end processes and systems, increase collaboration, and improve performance across trials. This reflects an industrywide shift, with nearly all (99%) respondents to the Veeva 2017 Unified Clinical Operations Survey reporting the need to unify their clinical operations.

“Sponsors are unifying systems and processes to improve study quality and execution while managing a growing number of trials and increasing complexity across the clinical lifecycle,” said Rik Van Mol, vice president, R&D Strategy, Europe at Veeva, in an official statement following the announcement. “Veeva Vault eTMF lets Debiopharm improve trial visibility and compliance as well as begin a journey toward unified clinical operations.”