{"id":63161,"date":"2022-03-10T16:34:13","date_gmt":"2022-03-10T15:34:13","guid":{"rendered":"http:\/\/www.veeva.com\/eu\/?page_id=63161"},"modified":"2026-03-30T21:10:17","modified_gmt":"2026-03-30T19:10:17","slug":"urogen-streamlines-clinical-and-regulatory-operations","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/urogen-streamlines-clinical-and-regulatory-operations\/","title":{"rendered":"UroGen"},"content":{"rendered":"<p>\nWith users working in both <a href=\"\/eu\/products\/veeva-rim\/\">³Ô¹Ï±¬ÁÏ RIM<\/a> and <a href=\"\/eu\/products\/clinical-operations\/\">³Ô¹Ï±¬ÁÏ Clinical Operations<\/a>, UroGen maintained separate<br \/>\nrepositories for their regulatory and clinical data and documents. This made cross-functional processes<br \/>\nlike preparing an IND update rather cumbersome as teams had to download documents from one system,<br \/>\nupload them in another, and track version numbers and status in a spreadsheet. These manual steps were<br \/>\ntime consuming, error prone, and resulted in the same file existing in multiple places.\n<\/p>\n<h2>Automatic Information Sharing<\/h2>\n<p>\nTo alleviate this challenge, UroGen decided to implement the ³Ô¹Ï±¬ÁÏ Clinical Operations to RIM Connection,<br \/>\nwhich seamlessly transfers data and documents between application suites. For example, when the<br \/>\nclinical team approves trial records like an audit certificate or Form 1572, the documents are automatically<br \/>\nshared in ³Ô¹Ï±¬ÁÏ Submissions. As a result, the regulatory team can more easily assemble IND updates and<br \/>\nclinical study report appendices with confidence that nothing is missing. Similarly, when the regulatory<br \/>\nteam approves a protocol change, the update is automatically shared in ³Ô¹Ï±¬ÁÏ eTMF, which helps clinical<br \/>\nkeep the TMF and study sites current.\n<\/p>\n<h2>Streamlined Processes<\/h2>\n<p>\nBy leveraging the ³Ô¹Ï±¬ÁÏ Clinical Operations to RIM Connection, UroGen has eliminated the manual<br \/>\ntransfers and tracking that raised the risk of delays, omissions, and duplicate files. The company has built<br \/>\na single source of truth with two-way information sharing that increases the visibility, quality, and speed of<br \/>\nclinical and regulatory activities\u2014a real advantage now that UroGen\u2019s first global phase three clinical trial is<br \/>\nunderway.\n<\/p>\n<p>\nMoving forward, UroGen will leverage the established connection framework to include new document<br \/>\ntypes and processes as they expand their global footprint.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With users working in both ³Ô¹Ï±¬ÁÏ RIM and ³Ô¹Ï±¬ÁÏ Clinical Operations, UroGen maintained separate<br \/>\nrepositories for their regulatory and clinical data and documents.<\/p>\n","protected":false},"featured_media":62787,"parent":0,"template":"","product-link-list":[],"class_list":["post-63161","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\/63161"}],"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\/63161\/revisions"}],"predecessor-version":[{"id":83021,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/63161\/revisions\/83021"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/62787"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=63161"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=63161"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}