{"id":89667,"date":"2025-11-06T05:00:04","date_gmt":"2025-11-06T04:00:04","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=89667"},"modified":"2026-07-03T17:51:45","modified_gmt":"2026-07-03T15:51:45","slug":"a-blueprint-for-clinical-trial-transformation-results-from-three-top-20-biopharmas","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/a-blueprint-for-clinical-trial-transformation-results-from-three-top-20-biopharmas\/","title":{"rendered":"A Blueprint for Clinical Trial Transformation: Results from Three Top 20 Biopharmas"},"content":{"rendered":"<br \/>\n<style>\n<p>.veeva-2024 .content-block__content>img {\n    margin: 4.6rem;\n}<\/p>\n<p>.veeva-2024 .content-block__content .content-pull-quote {\n    margin: 4.4rem 0;\n}<\/p>\n<p>.veeva-2024 .content-block__content blockquote {\n    padding: 1rem 3.2rem 1rem 2.4rem;\n}\n.veeva-2024 .content-block__content table {\n    margin-top: 3.6rem;\n    margin-bottom: 4.6rem;\n}<\/p>\n<p>@media (min-width:768px) {\n.veeva-2024 .hero-centered {\npadding: 100px 0;\n}\n}<\/p>\n<\/style>\n<p><img decoding=\"async\" class=\"img-responsive\" alt=\"\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-image-2-1252x574@2x.png\"><\/p>\n<h2 class=\"d-none\" data-toc-title=\"Introduction\">&nbsp;<\/h2>\n<p>A recent machine learning analysis of over 16,000 clinical trials has shown that <a href=\"https:\/\/www.nature.com\/articles\/s41598-024-53211-z#Sec2\" rel=\"noopener\" target=\"_blank\">trial complexity has increased over the last 10 years<\/a>, across all phases. Often, this is driven by the need to address previously unmet therapeutic targets and address regulatory requirements. More complex trials often result in longer timelines to bring medicines to patients, a higher likelihood of protocol changes, higher patient and investigator burdens, and greater chances of errors and biases. These are a few of many motivations for sponsors to transform their clinical technology and processes, in favor of a simpler trial environment [Figure 1].<\/p>\n<p><strong>This white paper highlights the recent clinical transformations of three top 20 biopharmas \u2014 Boehringer Ingelheim, Novo Nordisk, and Bayer<\/strong> \u2014 and includes the business cases, operating models, change management tactics, and results.<\/p>\n<p><img decoding=\"async\" class=\"img-responsive\" alt=\"\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/Figure-1_1400x435.png\"><\/p>\n<hr>\n<h2>Turning vision into success: Case examples<\/h2>\n<p>A vision for change succeeds when it\u2019s supported by a culture committed to new ways of working. This involves getting everyone aligned on shared goals, measuring progress, and clearly communicating the long-term benefits of the transformation. The following case studies demonstrate how leading organizations have used a clear vision, strategic planning, and dedication to improve <strong>efficiency<\/strong>, foster <strong>innovation<\/strong>, and enhance <strong>collaboration<\/strong> in clinical data management and clinical operations.<\/p>\n<blockquote>\n<h2 data-toc-title=\"\u2014 BOEHRINGER INGELHEIM:\u2028Replaced 40+ systems with a single platform across functions\" style=\"color:#f7981d;margin:0 0 5px 0;\">BOEHRINGER INGELHEIM<\/h2>\n<h3 style=\"color:#000;margin:0px;\">Replaced 40+ systems with a single platform across functions<\/h3>\n<\/blockquote>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"vision-value\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-1-332x65@2x.png\"><\/p>\n<p>Boehringer Ingelheim underwent a significant clinical transformation driven by the need to speed up time to submission. The cross-functional teams aimed to accelerate clinical programs by at least 300 days, and create more value from the data generated in its clinical trials.<\/p>\n<p>The company\u2019s vision was to consolidate fragmented processes onto a connected technology platform and empower its workforce. A comprehensive analysis revealed an opportunity to future-proof the system landscape. The biopharma company wanted to adopt a digital-first mindset to realize its platform goals \u2013 prompting the need for a foundational change.\u00a0<\/p>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"transformation\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-2-332x65@2x.png\"><\/p>\n<p>Boehringer Ingelheim planned a simultaneous implementation of four ³Ô¹Ï±¬ÁÏ Vaults \u2013 Clinical Data, Clinical Operations, Regulatory, and Quality \u2013 under its One Medicine Platform initiative. The team initiated the design stage for each Vault in parallel to understand the data model and process dependencies. Based on the initial design phase and the individual requirements of the different areas, the team opted for a phased go-live approach, starting with clinical data management as the team needed to replace a legacy system.\u00a0<\/p>\n<p>This phased implementation allowed teams to capture crucial learnings from each go-live, applying them to subsequent Vault deployments.\u00a0<\/p>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"key results\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-3-332x65@2x.png\"><\/p>\n<p><strong>Efficiency<\/strong>: Previously, site setup in the EDC system was manual, disconnected, and time-consuming. Boehringer Ingelheim implemented the ³Ô¹Ï±¬ÁÏ Clinical Operations-EDC Connection to automatically enter site setup from CTMS into EDC. This saved significant time for data transfer, monitoring, and support across dozens of studies. \u201cThis is a clear use case for where the platform is providing its value,\u201d comments Martin Heckenberger, capability owner, clinical data collection, Boehringer Ingelheim.<\/p>\n<p>In addition, implementing a modern EDC allowed the team to improve study build efficiency by bringing electronic case report form (eCRF) builds in-house from a functional outsourcing model. By upskilling internal data managers, this reduced handovers and removed the need for edit checks and custom functions, increasing overall efficiency and saving costs.<\/p>\n<p><strong>Innovation<\/strong>: The company transitioned from a complex environment of 40+ systems and 70+ interfaces to a single clinical platform. This consolidation accelerated its pace of innovation, allowing for system updates that previously took years to complete. For recruitment tracking, Boehringer Ingelheim replaced three custom interfaces across four systems with an automated, cross-functional data flow. The ³Ô¹Ï±¬ÁÏ Clinical Operations-EDC Connection eliminated weekly, error prone data transfers and provided \u201ca single source of truth in near real-time,\u201d according to Heckenberger.<\/p>\n<p><strong>Collaboration<\/strong>: Previously, siloed communications burdened sites with multiple contacts from different teams. The clinical transformation improved collaboration with sites by minimizing fragmented processes and through unified communication.<\/p>\n<p>Internal enablement was also an important component: \u201cWe wanted to bring all processes to a connected technology platform, and to empower our people. We wanted to make it clear which role has to do what and who is empowered to make which decisions,\u201d explains Heckenberger.<\/p>\n<div class=\"content-pull-quote\">\n<p>\u201cWe wanted to bring all processes to a connected technology platform, and to empower our people. We wanted to make it clear which role has to do what and who is empowered to make which decisions.\u201d<\/p>\n<div class=\"content-pull-quote__person\">\n<div class=\"content-pull-quote__author\">\n<h6>Martin Heckenberger<\/h6>\n<p>Capability Owner, Clinical Data Collection, Boehringer Ingelheim<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<blockquote>\n<h2 data-toc-title=\"\u2014 NOVO NORDISK:\u2028From implementation to scale-up within 12 months with a dedicated change management team\" style=\"color:#f7981d;margin:0 0 5px 0;\">NOVO NORDISK<\/h2>\n<h3 style=\"color:#000;margin:0px;\">From implementation to scale-up within 12 months with a dedicated change management team<\/h3>\n<\/blockquote>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"vision-value\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-1-332x65@2x.png\"><\/p>\n<p>Novo Nordisk needed to scale for growth and enable innovative trial design elements in new therapy areas. To do this, the company set out to simplify its digital landscape and improve user satisfaction. In partnership with its CRO partner, the company sought to replace its \u2018homegrown\u2019 solutions with a unified platform to ensure global consistency, quality, adoption, and accessibility.\u00a0<\/p>\n<div class=\"content-pull-quote\">\n<p>\u201cIt\u2019s not just about enabling innovative trial design and simplifying the digital landscape. Equally as important is improving end user satisfaction with the systems and increasing our process efficiency.\u201d\u00a0<\/p>\n<div class=\"content-pull-quote__person\">\n<div class=\"content-pull-quote__author\">\n<h6>Implementation Manager, Global CRO\u00a0<\/h6>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"transformation\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-2-332x65@2x.png\"><\/p>\n<p>Novo Nordisk began with the strategic decision to standardize on a single clinical data platform across all regions and therapeutic areas. The company adopted ³Ô¹Ï±¬ÁÏ EDC and DQS in 2024, with five trials live on the platform within 12 months and a further 20 planned for go-live in the following six months.<\/p>\n<p>The success of Novo Nordisk\u2019s transformation was deeply rooted in its comprehensive change management strategy with its CRO partner. This involved several teams with specific focuses, including dedicated efforts for site and CRA engagement, safety, and clinical adjudication. Staff captured critical end-user experiences, and subject matter experts were actively involved in workshops early in the process.<\/p>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"key results\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-3-332x65@2x.png\"><\/p>\n<p><strong>Efficiency<\/strong>: Early targets indicate reduced study set-up cycle times by 50% in initial trials, a 20% reduction in time and effort for study build, and a 20% reduction in time spent cleaning and monitoring data. The team is also on track to achieve a 1-day EDC build. These projections stem directly from streamlining processes and empowering users through direct system access.\u00a0<\/p>\n<p><strong>Innovation<\/strong>: With a solution-oriented mindset, Novo Nordisk launched the DataNow program, dedicated to digitizing processes for \u2018better, faster, and cheaper trials\u2019. This transformation has paved the way for new, innovative trial designs. For instance, a model study with four indications in one protocol was set up in just two weeks, showcasing the team\u2019s ability to initiate complex trials in the system.\u00a0<\/p>\n<div class=\"content-pull-quote\">\n<p>\u201cWhat\u2019s really exciting me is that once we have the connection between OpenStudyBuilder and ³Ô¹Ï±¬ÁÏ EDC and DQS in place, with a click of a button I can pull out the digital specification from OpenStudyBuilder for my trial, load that data in to ³Ô¹Ï±¬ÁÏ, and then we can automate the trial build. That\u2019s where the magic is going to happen.\u201d\u00a0<\/p>\n<div class=\"content-pull-quote__person\">\n<div class=\"content-pull-quote__author\">\n<h6>Ibrahim Kamstrup-Akkaoui\u00a0<\/h6>\n<p>VP Data Systems Innovation, Novo Nordisk<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<p><strong>Collaboration<\/strong>: Novo Nordisk focused its change management approach on processes that could significantly reduce administrative burden on people. For example, the reconciliation of serious adverse events (SAEs) between the safety database and EDC was previously a cumbersome process. It involved data managers manually exporting data to spreadsheets, sending it to safety teams for comments, and then re-entering information as queries. By giving its safety team direct access to ³Ô¹Ï±¬ÁÏ DQS, Novo Nordisk eliminated a significant administrative burden for data managers, removed error-prone spreadsheet tracking, and gave safety teams access to live data. This was a \u201cwin overall that took a little bit of creative thinking and collaboration,\u201d notes the CRO\u2019s implementation manager.\u00a0<\/p>\n<hr>\n<blockquote>\n<h2 data-toc-title=\"\u2014 BAYER:\u2028Projected 20% effort savings through connected clinical\u2028data flow\" style=\"color:#f7981d;margin:0 0 5px 0;\">BAYER<\/h2>\n<h3 style=\"color:#000;margin:0px;\">Projected 20% effort savings through connected clinical data flow<\/h3>\n<\/blockquote>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"vision-value\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-1-332x65@2x.png\"><\/p>\n<p>Bayer\u2019s move into cell and gene therapies brings new challenges as a large pharma company: working with a network of drug innovation providers and start-up biotech companies means adapting to a faster pace and providing them with the infrastructure to develop new therapies. This move also brings greater scientific complexity and new research site collaborations. Bayer was driven by the vision of a smoother patient journey, and \u201cbecoming the partner of choice for these satellite biotech organizations,\u201d as described by the company\u2019s Senior Director, Clinical Digital Innovation, Robert Bergann. <\/p>\n<p>Bayer\u2019s approach to clinical data transformation was guided by the philosophy: \u201cthink wild and develop resilience,\u201d according to Bergann. This meant prioritizing what would deliver short-term impact while building toward a long-term vision of a patient-centric ecosystem.\u00a0<\/p>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"transformation\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-2-332x65@2x.png\"><\/p>\n<p>Unlike a fixed, sequential rollout, Bayer opted for a more flexible, user-driven implementation. The company began with ³Ô¹Ï±¬ÁÏ Study Startup and eTMF in year one, adding ³Ô¹Ï±¬ÁÏ CTMS and Study Training in year three, before expanding to ³Ô¹Ï±¬ÁÏ EDC and DQS two years later.\u00a0<\/p>\n<p>As part of the company\u2019s migration plan to remove legacy systems, it implemented ³Ô¹Ï±¬ÁÏ DQS with a connector to its existing EDC system, before progressively moving studies over to ³Ô¹Ï±¬ÁÏ EDC. The standard implementation would have been to design the overall process for the full range of ³Ô¹Ï±¬ÁÏ applications, then add the connector. This decision, driven by user impact, demonstrated pragmatism rather than adhering to a strict standard. Bergann recommends \u201cfinding an easier way to start and get started.\u201d This approach allowed the team to gain early momentum and valuable insights.\u00a0<\/p>\n<p><img decoding=\"async\" style=\"width:320px;margin:25px 0 25px 0;\" alt=\"key results\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/web-blueprint-for-clinical-transformation-blurb-3-332x65@2x.png\"><\/p>\n<p><strong>Efficiency<\/strong>: Bayer redesigned its clinical data processes to enhance efficiency at scale. By strategically eliminating manual trackers and complex data conversion transformations, it anticipates significant gains, with an estimated 15-20% effort savings across operations. This focus on streamlining workflows directly contributes to faster and more reliable data handling.\u00a0<\/p>\n<p><strong>Innovation<\/strong>: A cornerstone of Bayer\u2019s transformation was the consolidation of its technology and processes. The team successfully replaced over 30 disparate applications and 80 integrations with a single primary platform, simplifying the technological footprint and accelerating capacity for innovation. Bayer is actively working toward a patient journey that relies on innovative trial designs and real-world data (RWD). The goal is to create a system that continues to improve the patient experience and keep them informed through the trial. This ultimately increases their chance of receiving crucial therapies.\u00a0<\/p>\n<p><strong>Collaboration<\/strong>: Bayer\u2019s transformation focused on its customers and end-users to ease the burden on sites and improve patients\u2019 lives. The team recognized that trust and transparency are core components of successful clinical platform adoption. By involving these stakeholders and prioritizing their experience, Bayer ensures that the technology serves the people using it and those it aims to help.\u00a0<\/p>\n<div class=\"text-center content-pull-quote content-pull-quote--bg-gradient-blue\">\n<p>Bayer strategically eliminated manual trackers and complex data conversion transformations, with estimated 15-20% effort savings across operations.<\/p>\n<\/div>\n<hr>\n<h2>Starting your clinical transformation journey\u00a0<\/h2>\n<p>Through careful consideration of the <a href=\"\/eu\/products\/veeva-clinical-platform\/\">³Ô¹Ï±¬ÁÏ Clinical Platform<\/a> and its value, Boehringer Ingelheim, Novo Nordisk, and Bayer embarked on clinical transformation journeys that align with each company\u2019s business case:\u00a0<\/p>\n<ul>\n<li><strong>Boehringer Ingelheim<\/strong> transitioned from a complex environment of 40+ systems and 70+ interfaces to a single clinical platform for clinical data, clinical operations, regulatory, and quality. The company will continue to add applications to each area and implement ³Ô¹Ï±¬ÁÏ Safety in the future.\u00a0<\/li>\n<li><strong>Novo Nordisk<\/strong> is on track to reduce early trial cycle times for study set-up by 50% and decrease the effort for study build and data monitoring by 20%, with ³Ô¹Ï±¬ÁÏ EDC and DQS.<\/li>\n<li><strong>Bayer<\/strong> added ³Ô¹Ï±¬ÁÏ EDC and DQS to its core clinical operations applications, and anticipates saving 15-20% effort by eliminating manual trackers and data transformations, streamlining processes to enhance efficiency at a global scale. The company plans to add ³Ô¹Ï±¬ÁÏ eCOA, Payments, Disclosure, and potentially RTSM in the next two years.\u00a0<\/li>\n<\/ul>\n<p>A mindset shift is underway. Connected clinical systems simplify the experience for sponsors, sites, and patients, streamlining data and document flow between them.\u00a0<\/p>\n<p>For sponsors of all sizes considering a clinical transformation, several key takeaways emerge:\u00a0<\/p>\n<p><img decoding=\"async\" class=\"img-responsive\" alt=\"\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2025\/11\/Figure-2_1400x1150.png\"><\/p>\n<p>Many companies are moving towards a fully connected approach for R&#038;D, streamlining cross-functional development processes by integrating clinical data and operations with safety, regulatory, and quality. By partnering with vendors of connected systems, organizations can accelerate development, enhance data integrity, and improve the clinical trial experience for site and patients.\u00a0<\/p<\n\n\n\n<p>Ready to transform your clinical approach? <a href=\"\/eu\/resources\/how-to-adopt-a-clinical-platform\/\">Find out<\/a> how to adopt a clinical platform.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; A recent machine learning analysis of over 16,000 clinical trials has shown that trial complexity has increased over the last 10 years, across all phases. Often, this is driven by the need to address previously unmet therapeutic targets and address regulatory requirements. More complex trials often result in longer timelines to bring medicines to&hellip;<\/p>\n","protected":false},"featured_media":89671,"parent":0,"template":"","class_list":["post-89667","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-area-20-clinical-data-management","resource-area-20-clinical-operations","resource-product-20-dqs","resource-product-20-epro","resource-product-20-edc","resource-type-white-papers"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/89667"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/resources"}],"version-history":[{"count":2,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/89667\/revisions"}],"predecessor-version":[{"id":99288,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/89667\/revisions\/99288"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/89671"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=89667"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}