\nFor many global life sciences companies, maintaining
\nan inspection-ready trial master file (TMF), gaining
\ninsights into study processes, and collaborating with
\nexternal partners requires significant time and manual
\nintervention. MSD has embarked on a company-wide
\nmission to update its TMF processes and technology
\nto ensure greater quality documentation and timeliness,
\nwhile making it easier for study personnel to reach critical
\nmilestones.\n<\/p>\n
\nMSD has a longstanding dedication to improve the health and well-being of people around the globe. Through the
\nyears, its researchers have helped to find new ways to treat and prevent illness \u2013 from the discovery of vitamin B1 to
\nthe first statins to treat high cholesterol. MSD\u2019s scientists have also helped develop many novel products to improve
\nanimal health, including vaccines and antibiotics.\n<\/p>\n
\nOn par with its commitment to developing innovative products, the company has a history of leveraging new
\ntechnologies to drive process improvement. MSD was one of the first life sciences companies to adopt early content
\nmanagement tools when most global pharmaceutical companies still relied on paper. However, its once \u201cstate-of-theart,\u201d
\non-premise system was now outdated, and it was increasingly difficult to find and retrieve clinical trial documents
\nfor filings and site inspections.\n<\/p>\n
\n\u201cWe were getting by with our legacy content management system, but our capabilities were severely limited. We
\nneeded an eTMF that was easier to use, access, and search so we could improve efficiency and always be prepared
\nfor health authority site visits and audits,\u201d explained Bryan Souder, associate director of project management at MSD.\n<\/p>\n
\n“With ³Ô¹Ï±¬ÁÏ eTMF, we estimate a 30% reduction in time
\nto find, import, and process documents.”
\n Bryan Souder, Associate Director, Project Management, MSD<\/span>\n<\/p><\/blockquote>\nThe Solution<\/h2>\n
\nMSD performed a rigorous search for an eTMF solution that would transform its clinical operations and enable
\nreal-time inspection-readiness of the TMF. MSD wanted a single source of truth for all its TMF documentation, so it
\nneeded to make sure the system was accessible to thousands of users around the world and all TMF processes could
\nbe executed entirely within the application.\n<\/p>\n\nAfter a thorough market evaluation, MSD selected cloud-based ³Ô¹Ï±¬ÁÏ eTMF, part of ³Ô¹Ï±¬ÁÏ Systems\u2019 ³Ô¹Ï±¬ÁÏ
\nClinical Platform of applications. \u201cWe had a high bar to meet, and ³Ô¹Ï±¬ÁÏ eTMF exceeded our expectations. It has the
\nTMF-specific workflows and templates that our old system lacked and it is extremely easy to use. We are now
\nconfident that everyone is following study SOPs, and we can track a deeper set of metrics to improve our operational
\nefficiency,\u201d said Souder.\n<\/p>\n\nMSD\u2019s decision to standardize on cloud-based ³Ô¹Ï±¬ÁÏ eTMF also aligned directly with the corporate initiative to move
\ninformation technology to the cloud. With no costly infrastructure to maintain and update, MSD can effectively scale
\nVault eTMF across all its studies, make sure it is always using the latest functionality, and be confident it is getting the
\nmost out of its investment.\n<\/p>\nPartnership for Success<\/h2>\n
\nAlmost immediately, ³Ô¹Ï±¬ÁÏ eTMF delivered tangible benefits to MSD worldwide. These include a fast global
\nimplementation, increased process efficiency, and real-time compliance.\n<\/p>\nFast Global Implementation<\/h3>\n
\nGlobal implementation of ³Ô¹Ï±¬ÁÏ eTMF took less than 11 months and included training more than 5,000 users and
\nmigrating over eight million documents. \u201cMaking any kind of technology change for a company of our size and
\nbreadth is not easy and never fast,\u201d explained Souder. \u201c³Ô¹Ï±¬ÁÏ stepped up, and together we delivered Vault eTMF
\nin lightning speed.\u201d\n<\/p>\n\n\u201cThe collaboration and cooperation between ³Ô¹Ï±¬ÁÏ and our whole team was incredible,\u201d added Rob Willis, director
\nof MRL global development, IT knowledge, and portals for MSD. \u201cIn fact, we use the successful Vault eTMF
\nimplementation as an example to model internally when adopting any new technology, and it proved to non-believers
\nthat ³Ô¹Ï±¬ÁÏ\u2019s cloud solution works in a validated environment.\u201d\n<\/p>\nIncreased Process Efficiency<\/h3>\n
\nMSD cites ³Ô¹Ï±¬ÁÏ eTMF\u2019s search capabilities as a huge efficiency driver. \u201cWith ³Ô¹Ï±¬ÁÏ eTMF, we estimate a 30%
\nreduction in time to find, import, and process documents,\u201d explained Souder. \u201cDocument searches for auditors that
\nused to take days now only take minutes in ³Ô¹Ï±¬ÁÏ eTMF. This is a major source of cost savings for us because this
\nfrees up time for users to work on higher-value tasks.\u201d\n<\/p>\n\nMany life sciences organizations move documents into the TMF only once they are final, making it difficult to retrieve
\nthe latest version and providing no insight into the efficiency of the process itself. In contrast, ³Ô¹Ï±¬ÁÏ eTMF ensures
\neveryone at MSD shares, reviews, and approves documents directly in the system, recording each step along the
\nway. Users can always find and work on the correct version, and managers can gain critical insights to reduce waste
\nand rework.\n<\/p>\nReal-time Compliance<\/h3>\n
\n³Ô¹Ï±¬ÁÏ eTMF\u2019s automated workflows ensure all stakeholders are adhering to standard operating procedures, and its
\nease of access guarantees users around the globe can find the documents they need when they need them. Auditors
\nand inspectors can quickly and accurately reconstruct how a trial was run with minimal effort.\n<\/p>\n\nAdditionally, ³Ô¹Ï±¬ÁÏ eTMF aligns with the TMF Reference Model, allowing MSD to leverage this industry standard for
\nstructuring content. \u201cThe way we structure content with ³Ô¹Ï±¬ÁÏ eTMF is much different and more consistent than
\nbefore, so we expected some adjustment,\u201d continued Souder, \u201cAccording to users, transitioning to the TMF Reference
\nModel has been more of a learning curve than the switch to ³Ô¹Ï±¬ÁÏ eTMF.\u201d\n<\/p>\nLooking Ahead<\/h2>\n
\nMSD looks forward to providing contract research organizations, sites, and other partners direct access to Vault
\neTMF to further improve process efficiency. \u201cWe outsource a lot of clinical studies. Being able to add study
\ninformation into Vault eTMF throughout the trial process \u2013 instead of sharing it back and forth via a hard drive or CDs
\nor even email \u2013 is a lot faster and less risky, and it provides greater visibility,\u201d said Willis.\n<\/p>\n\nThe company plans to continue improving document management and efficiency by leveraging ³Ô¹Ï±¬ÁÏ eTMF as a
\nstrategic asset for the entire global organization. \u201cHaving a single, authoritative source of truth in ³Ô¹Ï±¬ÁÏ eTMF is an
\nadvantage that impacts many different areas of our organization worldwide,\u201d said Souder. \u201cWe now have rich insights
\nabout our clinical processes, affording MSD the critical chance to make iterative and long-term improvements that
\ncan further increase efficiency and the clinical trial process. ³Ô¹Ï±¬ÁÏ eTMF is changing the way people think about
\ncontent at MSD.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"MSD has embarked on a company-wide mission to update its TMF processes and technology to ensure greater quality documentation and timeliness.<\/p>\n","protected":false},"featured_media":73578,"parent":0,"template":"","product-link-list":[],"class_list":["post-64582","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64582"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":5,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64582\/revisions"}],"predecessor-version":[{"id":64584,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64582\/revisions\/64584"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/73578"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=64582"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=64582"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}