Celltrion has implemented Veeva Systems’ Veeva Vault eTMF to improve visibility and compliance across trial master file (TMF) processes.
Veeva’s Vault eTMF is specially designed for the life sciences industry. It is claimed to be the only application that enables active TMF management for real-time inspection readiness and control.
The operating model, where all the processes and documents are managed, enables TMF management to be automated and allows it to maintain inspection readiness.
Celltrion head of clinical operations Sueun Song said: “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.
“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.”
Vault eTMF will enable Celltrion to possess a single source of truth for trial documentation that provides easy access for auditors and inspectors.
Veeva country manager for Korea Chris Shim said: “Life sciences organizations are choosing Veeva Vault eTMF for active TMF management to improve study quality in today’s highly regulated environment.
“We’re excited about the opportunity to work with companies such as Celltrion in Asia Pacific to modernise their trial processes.”
Vault eTMF, a part of the Veeva Vault Clinical Suite, is claimed to be the industry’s first cloud-based platform that includes CDMS, CTMS, and eTMF to combine clinical data management and clinical operations.
Based in South Korea, Celltrion is a biopharmaceutical company engaged in research, development, and manufacturing of biosimilars and innovative drugs.