{"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:\/\/pantheon.veeva.com\/eu\/customer-stories\/urogen-streamlines-clinical-and-regulatory-operations\/","title":{"rendered":"UroGen"},"content":{"rendered":"

\nWith users working in both Veeva RIM<\/a> and Veeva Clinical Operations<\/a>, UroGen maintained separate
\nrepositories for their regulatory and clinical data and documents. This made cross-functional processes
\nlike preparing an IND update rather cumbersome as teams had to download documents from one system,
\nupload them in another, and track version numbers and status in a spreadsheet. These manual steps were
\ntime consuming, error prone, and resulted in the same file existing in multiple places.\n<\/p>\n

Automatic Information Sharing<\/h2>\n

\nTo alleviate this challenge, UroGen decided to implement the Veeva Clinical Operations to RIM Connection,
\nwhich seamlessly transfers data and documents between application suites. For example, when the
\nclinical team approves trial records like an audit certificate or Form 1572, the documents are automatically
\nshared in Veeva Submissions. As a result, the regulatory team can more easily assemble IND updates and
\nclinical study report appendices with confidence that nothing is missing. Similarly, when the regulatory
\nteam approves a protocol change, the update is automatically shared in Veeva eTMF, which helps clinical
\nkeep the TMF and study sites current.\n<\/p>\n

Streamlined Processes<\/h2>\n

\nBy leveraging the Veeva Clinical Operations to RIM Connection, UroGen has eliminated the manual
\ntransfers and tracking that raised the risk of delays, omissions, and duplicate files. The company has built
\na single source of truth with two-way information sharing that increases the visibility, quality, and speed of
\nclinical and regulatory activities\u2014a real advantage now that UroGen\u2019s first global phase three clinical trial is
\nunderway.\n<\/p>\n

\nMoving forward, UroGen will leverage the established connection framework to include new document
\ntypes and processes as they expand their global footprint.<\/p>\n","protected":false},"excerpt":{"rendered":"

With users working in both Veeva RIM and Veeva Clinical Operations, UroGen maintained separate
\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":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t