Leading South Korean biopharmaceutical modernizes trial operations to maintain inspection readiness and have a comprehensive view of study status
PLEASANTON, Calif.–(BUSINESS WIRE)–#activeTMF—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.
Additional Information
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.
Forward-looking Statements
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 April 30, 2019. 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.
Contacts
Roger Villareal
Veeva Systems
925-264-8885
roger.villareal@veeva.com
Lisa Barbadora
Veeva Systems
610-420-3413
pr@veeva.com