Specialist European biopharmaceutical company keeps TMF constantly up-to-date to stay inspection-ready and improve collaboration during trials
BARCELONA, Spain–(BUSINESS WIRE)–Veeva Systems (NYSE: VEEV) today announced that Biotest, a German biopharmaceutical company specializing in plasma proteins, implemented Veeva Vault eTMF to achieve greater visibility across its European trials. Vault eTMF enables Biotest to manage all study documents and activities in real-time as the TMF is generated. Now the company can maintain a constant state of inspection readiness and give teams a complete view into TMF status for faster study execution.
“We are increasing our efficiency and inspection readiness due to improved accessibility of trial documents with Veeva Vault eTMF,” said Daniela Zipp, head of operations, clinical systems, and data management at Biotest. “The local Veeva team in Germany provided tremendous support to get us up and running quickly. We now have the foundation and metrics in place to improve our study processes and oversight.”
Vault eTMF enables active TMF management so Biotest can manage study processes and documents in one system, in real-time, as they are executed. Advanced reporting and dashboards provide insights into document and process status at all times. Full visibility into TMF completeness allows sponsors, CROs, and sites to work better together during trials and accelerate execution.
“Companies are modernizing clinical operations to drive more efficient trials and speed drug development,” said Rik Van Mol, vice president of Veeva Development Cloud in Europe. “Veeva Vault eTMF gives Biotest greater transparency into TMF quality to improve compliance and collaboration throughout the course of their study execution.”
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. (Read more…)
For more on Veeva Vault eTMF, visit: veeva.com/eTMF
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Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors, and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. Learn more at www.biotest.com.
About Veeva Systems
Veeva Systems Inc. is a leader in cloud solutions—including data, software, and services—for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 900 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. The company 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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