Veeva Systems (NYSE:VEEV) today announced that Celltrion, one of the top South Korean biopharmaceutical companies, implemented Veeva Vault eTMF to improve oversight across its trial master file (TMF) processes and achieve greater compliance.
Vault eTMF enables an active TMF operating model where all processes and documents are managed in one system, in real time, as they are executed. With this model, TMF management is automated and the TMF stays in a constant state of inspection readiness.
“Veeva Vault eTMF will help us streamline our clinical operations and give us a complete view of study documents at every stage of drug development,” said Sueun Song, head of clinical operations at Celltrion. “As clinical trials become more complex, we need advanced insights into study processes and the ability to stay compliant with regulatory authorities around the world.”
Recent ICH E6(R2) amended guidelines require sponsors to maintain oversight throughout the clinical trial lifecycle. With Vault eTMF, Celltrion has a single source of truth for trial documentation that provides simplified access for auditors and inspectors. Moving to Vault eTMF, Celltrion also improves operational performance and strengthens collaboration with study partners and sites.
“Life sciences organizations are choosing Veeva Vault eTMF for active TMF management to improve study quality in today’s highly regulated environment,” said Chris Shim, country manager for Veeva Korea. “We’re excited about the opportunity to work with companies such as Celltrion in Asia Pacific to modernize their trial processes.”
Veeva Vault eTMF is part of the Veeva Vault Clinical Suite, the industry’s first cloud platform that includes CDMS, CTMS, eTMF, and study start-up to unify clinical data management and clinical operations. Veeva’s suite of unified applications provides global visibility into trial activities and streamlines end-to-end clinical processes. For more information, visit veeva.com/Clinical.
For more on Veeva Vault eTMF, visit: veeva.com/eTMF
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About Celltrion Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company specializing in research, development, and manufacturing of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EMA approval for Inflectra and Remsima, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit celltrion.com.
About Veeva Systems
Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 750 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.
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