\nSince 2016, Atara Biotherapeutics has worked with ³Ô¹Ï±¬ÁÏ to centralize regulatory data and documents, align cross-functional teams, and automate manual processes. As the biotech company continues to grow, ³Ô¹Ï±¬ÁÏ VRIM is evolving with them to help keep pace in a rapidly changing environment.\n<\/p>\n
\nIn early 2020, Atara kicked off an initiative to better prepare its regulatory organization for the future. The company was
\nunderutilizing ³Ô¹Ï±¬ÁÏ RIM, so it launched an optimization program to maximize the solution\u2019s existing value while also adding
\nnew capabilities to prepare for anticipated growth. Atara focused its efforts on improving ³Ô¹Ï±¬ÁÏ Submissions, adopting ³Ô¹Ï±¬ÁÏ
\nRegistrations for registration tracking, and ³Ô¹Ï±¬ÁÏ Submissions Publishing to support in-house publishing of
\nupcoming marketing applications.\n<\/p>\n
\nIn parallel, Atara overhauled its system implementation practices to streamline validation efforts and bring new functionality
\nto users. The company adopted an agile, risk-based approach to validating new functionality that allowed for more frequent,
\nincremental upgrades and improved user adoption. These methodology updates continue to accelerate the deployment of
\nAtara\u2019s configuration changes along with innovations in ³Ô¹Ï±¬ÁÏ RIM\u2019s regular release cycles.\n<\/p>\n
\nAtara activated ³Ô¹Ï±¬ÁÏ Submissions Publishing to streamline the European MAA submission for its inaugural commercial product, marking it as the first approved allogeneic T-cell cancer therapy. Previously, the company had outsourced its submission publishing projects, relying on disjointed folders and binders to manage information and document exchanges with contract partners.\n<\/p>\n
\nMatt Neal, head of regulatory affairs and quality, sought to bring these efforts in-house, believing that a continuous publishing approach would eliminate the time constraints from traditional submissions publishing tools and approaches. The primary objectives included facilitating earlier review, handoffs, and rework management in the publishing process, while also distributing project management responsibilities across teams.\n<\/p>\n
\n³Ô¹Ï±¬ÁÏ\u2019s platform streamlined Atara\u2019s submissions publishing and removed bottlenecks by centralizing access to required documents and information. Expert authors can now collaborate, link, and create content independently and in parallel, accelerating review and validation times and reducing time constraints. Authors and publishers can also work together on an overall content plan that addresses key project management issues like author and reviewer workloads. Gaining cross-functional transparency eliminates risks from one person managing all the tasks across multiple teams.\n<\/p>\n
\nThe platform has \u201cunleashed power that users didn\u2019t know they had,\u201d says Neal, by leveraging Vault RIM\u2019s real-time access to documents and data throughout the product life cycle. Improved data access can reduce the risk of receiving \u201crefusal to file\u201d responses from regulators by exposing documentation gaps earlier in the cycle. For Atara, the new platform has elevated the submissions publishing professional\u2019s role to that of an advisor, Neal adds. \u201cNot on the science or clinical side, perhaps, but on how the submission should look when it reaches regulatory agency reviewers.\u201d\n<\/p>\n
\nThe unified ³Ô¹Ï±¬ÁÏ RIM solution is fast becoming a strategic asset to Atara, and will continue to evolve as the company
\nprepares for commercialization. They now have access to information that\u2019s connected and readily available in an
\nauthoritative system, which supports faster, more effective decisions. As a result, Atara staff are starting to see
\nimprovements in operational processes and in the quality of their work products.\n<\/p>\n
“A RIM system starts to become a strategic asset for organizations that do it right.”
\n\u2013 Matt Neal, Senior Director Regulatory Affairs Operations, Atara Biotherapeutics<\/span>\n<\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"Atara launched an optimization program to maximize RIM value and add new capabilities.<\/p>\n","protected":false},"featured_media":62392,"parent":0,"template":"","product-link-list":[1401,1418,1427,1437,1438,1440],"class_list":["post-65044","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry","product-link-list-veeva-crm-suite","product-link-list-veeva-etmf","product-link-list-veeva-medcomms","product-link-list-veeva-promomats","product-link-list-veeva-qms","product-link-list-veeva-qualitydocs"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/65044"}],"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":4,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/65044\/revisions"}],"predecessor-version":[{"id":84821,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/65044\/revisions\/84821"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/62392"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=65044"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=65044"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}