BOSTON–Halloran Consulting Group, Inc. (Halloran) today announced its collaboration with Veeva Systems (Veeva), providing a combination of technology and services to enable rapid access to Vault eTMF and ongoing Trial Master File (TMF) maintenance.
Vault eTMF, part of Veeva’s cloud-based suite of content management applications built specifically for the life sciences, is a process-driven clinical application used to plan, manage, and archive clinical trial-related documentation. These Trial Master File documents, which demonstrate compliance with clinical trial regulations and Good Clinical Practices (GCPs), are typically maintained in a variety of paper and electronic locations, sometimes without adequate controls. Vault eTMF revolutionizes the capture and maintenance of the TMF by bringing together sponsors, clinical research organizations (CROs), and investigative sites and their documents in the regulated cloud, ensuring that the TMF is easily accessible, searchable, and readily reportable.
Together, Veeva and Halloran have the capabilities needed to transition a life science company from a paper TMF operating model to a fully electronic TMF operating model, without disrupting the flow of normal business operations. Halloran provides companies access to a validated instance of Vault eTMF that can be accessed by Halloran customers, putting this technology within the grasp of emerging sponsors and site networks. During study conduct, Halloran’s experts serve as the client’s document management team, administering the system and performing regular quality control reviews of the files for document legibility, completeness, and filing accuracy, providing a fully outsourced eTMF model to clients. Veeva and Halloran provide a combination of technology and services to enable rapid access and efficient administration and management of end-to-end eTMF business operations.
“I am excited about Veeva’s collaboration with Halloran; together we will provide life science companies with cutting edge technology, combined with best-in-breed clinical services that can transform an organization’s eTMF capability from a tactical asset to a strategic one,” says Jennifer Goldsmith, Vice President of Veeva Vault. “This alliance with Halloran helps companies keep their focus where it needs to be: on the vital business of managing clinical studies.”
“Veeva Vault eTMF, combined with Halloran’s clinical expertise and services, is a game-changer for sponsors,” says Laurie Halloran, President and CEO of Halloran Consulting Group. “Every development-stage life sciences company should have access to this enterprise-level technology. Our support allows those companies to benefit from Veeva’s capabilities without investing in a large infrastructure of IT, Quality Assurance, and Central Files personnel. ”
About Halloran Consulting Group
Halloran Consulting Group is a management consulting firm that partners with life science companies to guide them through today’s complex clinical landscape. Halloran works with industry organizations of all types, including biotech, pharma, medical device, and life science service providers, to streamline procedures and maximize available resources. Halloran provides on-demand expertise to complement development teams and fills gaps in clinical, regulatory, quality, and program management capabilities. For more information, please visit www.hallorancg.com.
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 200 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, please visit www.veeva.com.
Halloran Corporate Contact:
Halloran Consulting Group, Inc.
Elizabeth Schaul, 617-648-7879