{"id":69421,"date":"2023-02-15T22:24:24","date_gmt":"2023-02-15T21:24:24","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?page_id=69421"},"modified":"2026-02-21T01:08:21","modified_gmt":"2026-02-21T00:08:21","slug":"heron-therapeutics-streamlines-clinical-trials-with-a-modern-ctms","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/heron-therapeutics-streamlines-clinical-trials-with-a-modern-ctms\/","title":{"rendered":"Heron Therapeutics"},"content":{"rendered":"<p>\nRunning efficient clinical trials is essential for emerging<br \/>\nbiotechs to achieve growth at scale. A key aspect of<br \/>\nimproving the speed, timeliness, costs, and accuracy of<br \/>\ntrials is implementing a clinical trial management system<br \/>\n(CTMS) that is optimized for business operations. Heron<br \/>\nTherapeutics, a biotech company with three commercial<br \/>\nproducts and over 10 studies running in various stages<br \/>\nat any given time, develops therapies for oncology and<br \/>\nacute care.\n<\/p>\n<p>\nHeron applies its innovative science and technologies to<br \/>\ndevelop patient-focused treatments. The company has implemented the ³Ô¹Ï±¬ÁÏ RIM, ³Ô¹Ï±¬ÁÏ Quality, and several applications within ³Ô¹Ï±¬ÁÏ Clinical Operations \u2014 including <a href=\"https:\/\/www.veeva.com\/eu\/products\/veeva-ctms\/\">³Ô¹Ï±¬ÁÏ CTMS<\/a>. With over 50<br \/>\nactive sites and counting, Heron\u2019s implementation of ³Ô¹Ï±¬ÁÏ CTMS enables proactive trial management,<br \/>\noperational efficiency, and improved collaboration, among other advantages.\n<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.veeva.com\/eu\/wp-content\/uploads\/2023\/02\/highlights.png\" alt=\"\" width=\"800\" height=\"228\" class=\"img-responsive mb-20\" \/><\/p>\n<h2>Drivers for implementing a new clinical trial management system<\/h2>\n<p>\nRealizing the need to speed trials, gain greater visibility, and improve study analytics, Heron implemented a CTMS<br \/>\nwith another provider in 2017, but the system was not user-friendly or intuitive, and it didn\u2019t easily integrate with<br \/>\nthe company\u2019s other clinical systems. The CTMS wasn\u2019t adopted by users.\n<\/p>\n<p>\nWhen Susan Stamford, Heron\u2019s executive director of clinical operations, joined the company in 2019, one of her<br \/>\nkey tasks was to replace the existing CTMS with a more modern system that better aligned with Heron\u2019s values,<br \/>\ngoals, strategies, and systems. \u201cI knew we needed a solution that could support our growth and that was in line<br \/>\nwith our other operational activities,\u201d said Stamford. \u201cOne of the most important criteria was having a single<br \/>\nsource of truth so we could easily pull data together in one place to reduce errors.\u201d\n<\/p>\n<p>\nHeron relied heavily on Word documents and Excel trackers that required multiple manual reviews for quality<br \/>\ncontrol. Based on prior experience, Heron\u2019s clinical leaders knew they had to digitize as many processes and<br \/>\nactivities as possible and focus on preparing the organization for change to drive the adoption of new technology.<br \/>\n\u201cI had a lot of sleepless nights thinking about CTMS implementation, especially when our prior solution was in<br \/>\nplace,\u201d said Stamford, who has worked in clinical operations for more than 25 years. \u201cThey stopped once we<br \/>\ndecided to implement ³Ô¹Ï±¬ÁÏ and actually started the implementation.\u201d<\/p>\n<p>\n<vid class=\"mt-0\"><br \/>\n<script src=\"https:\/\/fast.wistia.com\/embed\/medias\/z6c4zzr2s2.jsonp\" async><\/script><\/p>\n<div class=\"wistia_responsive_padding\" style=\"padding:56.25% 0 0 0;position:relative;\">\n<div class=\"wistia_responsive_wrapper\" style=\"height:100%;left:0;position:absolute;top:0;width:100%;\">\n<div class=\"wistia_embed wistia_async_z6c4zzr2s2 videoFoam=true\" style=\"height:100%;position:relative;width:100%\">\n<\/div>\n<\/div>\n<\/div>\n<p><\/vid><\/p>\n<h2>Developing best practices for CTMS implementation and training strategies<\/h2>\n<p>\nTo address their clinical trial management challenges and needs, Heron\u2019s team decided to implement ³Ô¹Ï±¬ÁÏ CTMS<br \/>\nto take advantage of the unification with ³Ô¹Ï±¬ÁÏ eTMF, partnering closely with ³Ô¹Ï±¬ÁÏ but overseeing the project<br \/>\nthemselves. Since Heron had already collaborated with ³Ô¹Ï±¬ÁÏ to launch ³Ô¹Ï±¬ÁÏ eTMF, the CTMS implementation<br \/>\nproceeded smoothly.\n<\/p>\n<p>\nUsing an agile approach, the team met all project deadlines. Unifying CTMS with eTMF has enabled the clinical<br \/>\nteam to streamline operations and speed up clinical trials. \u201cThis was a natural partnership for us because of our<br \/>\nfamiliarity with ³Ô¹Ï±¬ÁÏ\u2019s platform and their team\u2019s expertise in business processes, project management, and<br \/>\nsystems,\u201d Stamford said.\n<\/p>\n<p>\nAlthough Heron and ³Ô¹Ï±¬ÁÏ were both accustomed to conducting training and implementation onsite, they quickly<br \/>\npivoted to online strategies when the pandemic struck. Heron\u2019s team followed ³Ô¹Ï±¬ÁÏ\u2019s agile implementation to<br \/>\nensure that end users were prepared for change and ready to execute trials by: <\/p>\n<ul>\n<li>Creating small, integrated teams and holding regular cross-functional team meetings to discuss<br \/>\nthe execution and status of activities<\/li>\n<li>Aligning on expectations internally for user acceptance testing and developing tip sheets with<br \/>\nscreenshots for reference<\/li>\n<li>Providing just-in-time training with ongoing support based on individual needs and delivering<br \/>\ntrain-the-trainer sessions customized by role<\/li>\n<li>Having subject matter experts (SMEs) test solutions in a real-time sandbox environment to<br \/>\n\u201ctest drive\u201d the system<\/li>\n<\/ul>\n<p>\n\u201cWe engaged SMEs early and often, encouraging them to flag questions and recommend innovative approaches,\u201d<br \/>\nStamford said. \u201cAnd giving the team job aids like tip sheets with step-by-step instructions and screenshots was<br \/>\nvery helpful. People could refer to them if they forgot something or needed a refresher.\u201d\n<\/p>\n<h2> Improving clinical trials with the right CTMS<\/h2>\n<p>\nHeron\u2019s successful rollout of ³Ô¹Ï±¬ÁÏ CTMS has provided many benefits. In addition to being easy to use and adopt,<br \/>\nthe application has reduced the manual processes once required for monitoring events\u2014including confirmation<br \/>\nletters, visit reports, and follow-up letters, cutting the time required for each event by 30 minutes. Filing time per<br \/>\ndocument has been reduced to 10 minutes.\n<\/p>\n<p>\nThe benefits of unifying CTMS and eTMF are clear. Once documents are finalized in ³Ô¹Ï±¬ÁÏ CTMS, they<br \/>\nautomatically populate in ³Ô¹Ï±¬ÁÏ eTMF, making data easily searchable and accessible. The organization reviews<br \/>\nprotocol deviations monthly in ³Ô¹Ï±¬ÁÏ CTMS and relies on version-controlled audit trails to guide discussions.<br \/>\nThe study team consistently meets its target for visit report timeliness, and study-level decisions can be made<br \/>\nmore easily.\n<\/p>\n<h2>What\u2019s on the horizon<\/h2>\n<p>\nAs Heron grows and refines its systems and processes, its clinical team remains focused on creating a culture<br \/>\nof continuous improvement, in which members are constantly learning and developing new tools based on best<br \/>\npractices. The team aims to implement the risk-based quality management features in ³Ô¹Ï±¬ÁÏ CTMS to manage<br \/>\nstudy risks more proactively, create more dashboards, and automate information flows with sites using ³Ô¹Ï±¬ÁÏ<br \/>\nSite Connect.\n<\/p>\n<p>\nFor more information on CTMS change management and implementation best practices, <a href=\"https:\/\/www.veeva.com\/resources\/how-to-stop-worrying-and-love-your-ctms\/\">view this whitepaper<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Implementing ³Ô¹Ï±¬ÁÏ Vault CTMS enabled Heron Therapeutics to automate manual processes, get better visibility into study progress, and make clinical trials more efficient. <\/p>\n","protected":false},"featured_media":68430,"parent":0,"template":"","product-link-list":[1418,1437,1439,1451,1455],"class_list":["post-69421","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry","product-link-list-veeva-etmf","product-link-list-veeva-promomats","product-link-list-veeva-quality-cloud","product-link-list-veeva-submissions","product-link-list-veeva-training"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/69421"}],"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":8,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/69421\/revisions"}],"predecessor-version":[{"id":84629,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/69421\/revisions\/84629"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/68430"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=69421"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=69421"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}