Debiopharm International SA Strengthens Compliance and Clinical Trial Oversight With Veeva Vault eTMF
Published: Apr 17, 2018
“Veeva is helping us streamline our clinical operations,” said Christian A. Aeschlimann, director of clinical operations at Debiopharm. “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,” said Vincent Demeautis, clinical operations manager at Debiopharm. “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," said Sofie Lemmens, senior clinical trial associate at Debiopharm, who led the implementation of Veeva Vault eTMF. "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. “Veeva Vault eTMF lets Debiopharm improve trial visibility and compliance as well as begin a journey toward unified clinical operations.”
Veeva Vault eTMF is part of Veeva Vault Clinical Suite, the industry's first suite of applications that combines eTMF with EDC, CTMS, and study start-up to unify clinical data management and operations. To learn how organizations are eliminating system silos across clinical operations with Veeva Vault Clinical Suite, visit veeva.com/Clinical.
For more on Veeva Vault eTMF, visit: veeva.com/eTMF
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About Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 600 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit veeva.com.
About Debiopharm International SA
Part of Debiopharm Group™ – a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management – Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide. For more information, please visit debiopharm.com or follow @DebiopharmNews on Twitter.
This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the company’s filing on Form 10-Q for the period ended
October 31, 2017. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.
Source: Veeva Systems Inc.