\nThis year at ³Ô¹Ï±¬ÁÏ R&D and Quality Summit in Madrid<\/a> and Boston<\/a>, biopharma companies, sites, and contract research organizations (CROs) shared how their organizations innovate and achieve efficiency amidst clinical trial complexity. Discussions centered around simplifying and standardizing operations for better experiences across sponsors, CROs, sites, and patients.\n<\/p>\n \nFor example, Amgen\u2019s Executive Director of Global Statistical Programming, David Hansen, shared how the company is preparing to scale transformative change. He echoed the sentiment<\/a> of Scott Skellenger, SVP and CIO at Amgen that \u201cwith ³Ô¹Ï±¬ÁÏ, we’re unlocking new capabilities for our end-to-end trial operations<\/strong> to further strengthen our ability to bring innovative treatments to patients with speed and scale.\u201d\n<\/p>\n Below are recent clinical data outcomes achieved by the industry:<\/p>\n \n\u201cWe don\u2019t have the pain points we had in the BV days (\u2018Before ³Ô¹Ï±¬ÁÏ\u2019) \u2013 the planned and the unplanned downtime, which is really a killer for CRAs and sites.\u201d \u2013 Jennifer Scheller, Senior VP, Head of Global Clinical Trial Operations<\/p>\n \nWatch the session<\/a>\n<\/p>\n<\/li>\n \n\u201cThe clean patient tracker is a powerful tool in achieving risk-based data management by visualizing all CDB data.\u201d With ³Ô¹Ï±¬ÁÏ EDC and CDB, GSK is achieving:<\/p>\n \n\u201cWe have a host of bespoke tools and a tendency to overcustomize, so our goal moving forward is to simplify our operating model by shifting to out-of-the-box ³Ô¹Ï±¬ÁÏ tools.\u201d \u2013 Jo Kosinkas, Director, Clinical Data Management\n<\/p>\n<\/li>\n Novo Nordisk:<\/strong> \u201cTo support the scale-up of our growing trial portfolio and making new drugs available faster to our patients, we\u2019re seeing good signs of reducing trial setup timelines by 50% in ³Ô¹Ï±¬ÁÏ EDC and CDB. We\u2019re going for a standard setup timeline of just four weeks, and that\u2019s without all the automations that we have planned.\u201d \u2013 Ibrahim Kamstrup-Akkaoui, VP Data Systems Innovation.<\/p>\n \nEarly targets include:<\/p>\n Watch the session<\/a><\/li>\n Bayer:<\/strong> By decommissioning 30+ applications and 80+ integrations and replacing them with ³Ô¹Ï±¬ÁÏ Clinical Platform, Bayer predicts 15-25% savings from streamlining processes across departments.<\/p>\n \n\u201cWe will arrive at a simplified landscape that doesn\u2019t take all our money, brains, and time to maintain\u201d \u2013 Robert Bergann, Senior Director, Clinical Digital Innovation<\/p>\n<\/li>\n Boehringer Ingelheim:<\/strong> The company consolidated 40+ systems and 70+ interfaces into a single clinical platform, and saved time on data transfer, monitoring, and support by automating site setup from ³Ô¹Ï±¬ÁÏ CTMS to EDC.<\/p>\n \n\u201cWe have eliminated error-prone data transfer and have achieved cross-functional data flow\u201d \nWatch the session<\/a>\n<\/p>\n<\/li>\n Global medtech company:<\/strong> With 200 studies in ³Ô¹Ï±¬ÁÏ EDC and 60 studies in CDB, the company averages 10 days from last patient last visit (LPLV) to database lock (DBL). The team recently expanded its use of ³Ô¹Ï±¬ÁÏ’s Clinical Platform to include ³Ô¹Ï±¬ÁÏ RTSM and ³Ô¹Ï±¬ÁÏ eCOA, and now average three days for survey builds and have 92% compliance across all studies.<\/p>\n “This is the fastest that we have installed to date. We went live on the system 20 days after signing, thanks to our using the out-of-the-box application.” \u2013 Head of Clinical Data Operations<\/p>\n<\/li>\n<\/ul>\n \n“We received positive feedback from patients and site staff, and are delivering a positive ROI, projected to save millions.” \nWatch the session<\/a><\/p>\n<\/li>\n Endo and Atorus:<\/strong> The emerging biotech partnered with Atorus\u2019 data management team to bring ³Ô¹Ï±¬ÁÏ EDC and CDB in house. The teams are achieving greater build efficiency with each study through CRF reuse, increased sponsor oversight with ³Ô¹Ï±¬ÁÏ CDB, and reduced time to DBL.<\/p>\n \n I was uncertain if I had the staff, the infrastructure, or the SOPs to be able to bring ³Ô¹Ï±¬ÁÏ EDC in-house. But we did and it took less time than I imagined.\u201d \u2013 Megan Halenda, Associate Director, Clinical Data Management, Endo.\n<\/p>\n \u201cHaving oversight within the system feels like a dream come true. ³Ô¹Ï±¬ÁÏ CDB eliminates some of the complexity that comes up from time to time.\u201d \u2013 Christine Kanalis, Executive Director, Clinical Data Management, Atorus<\/p>\n<\/li>\n \n\u201cOur effort to connect the study across different applications has gone from three months to five minutes. Checking two radio boxes on the EDC side.\u201d \nBiopharma companies and CROs are achieving faster study timelines, improved patient experiences, and major cost savings with a connected platform approach. These outcomes highlight the advantages of focusing on user needs and building strong partnerships.\n<\/p>\n \nIf you\u2019re looking to transform your clinical trials and learn more from industry leaders who are driving change, check out the white paper: A Blueprint for Clinical Trial Transformation<\/a>.\n<\/p>\n \nYou can gain further insights and make connections by attending the ³Ô¹Ï±¬ÁÏ R&D and Quality Summit Europe<\/a> and United States<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":" Discover how leading biopharma companies are overcoming clinical trial challenges with connected systems, featuring key successes and advice from the ³Ô¹Ï±¬ÁÏ EU R&D & Quality Summit.<\/p>\n","protected":false},"author":427,"featured_media":77190,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"product":[982,985,984,983,987,1031],"area":[970,971],"coauthors":[1573],"class_list":["post-85497","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","product-clinical-database-cdb","product-ctms","product-ecoa","product-edc","product-etmf","product-rtsm","area-clinical-data","area-clinical-operations","blog-area-rd","blog-product-data","blog-html-content-yes","region-eu"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/85497"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/users\/427"}],"replies":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/comments?post=85497"}],"version-history":[{"count":28,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/85497\/revisions"}],"predecessor-version":[{"id":90036,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/posts\/85497\/revisions\/90036"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/77190"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=85497"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/categories?post=85497"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/tags?post=85497"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product?post=85497"},{"taxonomy":"area","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/area?post=85497"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/coauthors?post=85497"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Improving end-to-end efficiency and streamlining processes<\/h3>\n
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\n\u2013 Valerie Balosso, Senior Director Data Strategy and Management<\/span>\n<\/p><\/blockquote>\n\n
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\n\u2013 Martin Heckenberger, Capability Owner Clinical Data Collection<\/span>\n<\/p><\/blockquote>\nModernizing eCOA operations and site experiences<\/h2>\n
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\n\u2013 Edwin Erkens, Chief Digital Technology Officer<\/span>\n<\/p><\/blockquote>\nGaining clinical data ownership and oversight<\/h2>\n
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\n\u2013 Senior IT Business Relationship Manager Clinical and Regulatory<\/span>\n<\/p><\/blockquote>\n<\/li>\n<\/ul>\nContinuing the journey<\/h3>\n