{"id":78247,"date":"2024-07-12T23:06:05","date_gmt":"2024-07-12T21:06:05","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=78247"},"modified":"2026-02-19T17:44:12","modified_gmt":"2026-02-19T16:44:12","slug":"outsourcing-clinical-trial-activities-without-sacrificing-study-oversight","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/outsourcing-clinical-trial-activities-without-sacrificing-study-oversight\/","title":{"rendered":"Outsourcing Clinical Trial Activities Without Sacrificing Study Oversight"},"content":{"rendered":"<style>\nul.column-list {\ncolumns: 300px  2;\n}\n.resources-content ul li, .resources-content ol li {\nmargin-top:5px;\nmargin-bottom:5px;\npadding: 0px;\n}<\/p>\n<p>.white {\ncolor:white;\n}\n.orange-line {\nborder-left:2px solid #F5961D;padding-left:24px;margin-left:30px;padding-right:30px;\n}\n@media screen and (max-width: 650px) {\n\t.orange-line {\nborder-left: 2px solid #F5961D;\npadding-left: 24px;\nmargin-left: 00px;\npadding-right: 00px;\n}\n}<\/p>\n<\/style>\n<p>As the pressure to bring new drugs to market faster increases, emerging biopharmas are turning to outsourcing to speed their trials. Outsourcing allows sponsors to leverage CRO expertise to navigate the intricacies of global trials.\n<\/p>\n<p>\nBut, the practice introduces a critical challenge: maintaining proper oversight. Without a clear view into trial operations, sponsors risk data quality problems and serious compliance gaps.\n<\/p>\n<h2>Hidden challenges in outsourced clinical trials<\/h2>\n<p>Despite CROs\u2019 resources, reach, and infrastructure, sponsors often encounter obstacles when outsourcing trials that can impact timely study execution.<\/p>\n<ul>\n<li><strong>Fragmented data:<\/strong> Data resides in various CRO systems, spreadsheets, and legacy  databases. This makes it difficult to gain a holistic view of trial progress, hinders informed decision-making, and delays reporting. <\/li>\n<li><strong>Communication silos:<\/strong> Silos can form between sponsor and CRO teams, leading to misunderstandings, delays, and quality issues. Critical updates can get lost, and timelines can slip due to a lack of clear and consistent communication channels.<\/li>\n<li><strong>Oversight burden:<\/strong> Ensuring adherence to regulations across multiple CROs, each with its own processes and systems, becomes a major hurdle. The risk of inconsistencies and errors increases dramatically, diverting resources and focus from core trial activities.<\/li>\n<li><strong>Inadequate technology:<\/strong> Many sponsors rely on tools like spreadsheets and data lakes to monitor the progress of their outsourced trials. These solutions aren&#8217;t built to handle the complex requirements of clinical trials, leading to data integrity issues and delays.<\/li>\n<\/ul>\n<blockquote>\n<h2 class=\"mt-15\">Are you at risk for a critical inspection finding?<\/h2>\n<p>Sponsors who are unable to show adequate documentation of their oversight can be penalized with severe fines from regulatory bodies.<\/p>\n<\/blockquote>\n<p>Beyond the challenges, however, are effective solutions. A CTMS can act as a bridge, connecting disparate teams and data, fostering collaboration, and ensuring smoother processes.<\/p>\n<h2>Bridging the gap: the CTMS advantage<\/h2>\n<p>By providing a central platform for study oversight, communication, and information sharing, a CTMS eliminates silos, fosters real-time transparency, and ensures alignment across all trial partners. This improved communication and visibility allows for faster issue identification and resolution, accelerating the path to more efficient trials.\u00a0<\/p>\n<p>Bonne Adams is the vice president of operations at Inhibrx Biosciences, a clinical-stage biotech with a lean team of 17 clinical and four IT employees. Even though Inhibrx outsources 75% of its studies to CROs, Adams still views the company\u2019s CTMS as essential. \u201cThe CTMS is your base system for setting up all other systems. Study metrics, global contacts \u2013 they all flow from your CTMS to other systems,\u201d Adams explains.<\/p>\n<p>Documenting a comprehensive oversight plan, a critical step for regulatory compliance, is straightforward with a CTMS. You can clearly define roles and responsibilities for both sponsor and CRO teams, monitor performance metrics to ensure CROs adhere to agreed-upon timelines, conduct co-monitoring visits, and capture all activities and communications to make compliance audits easy.<\/p>\n<div class=\"gray-box\" style=\"border-radius: 50px; background: #F1F3F6;padding-left:40px\">\n<div class=\"orange-line\">\n<h2 class=\"mt-15\">Why do I need a CTMS if a CRO runs my trials?<\/h2>\n<p>A CTMS centralizes planning, performance tracking, subject information, deadlines, oversight, and trial milestones in a simple and direct way. Having an auditable and reportable record of oversight activities is critical to satisfy regulatory requirements.<\/p>\n<\/div>\n<\/div>\n<blockquote><p>\n \u201cThe CTMS is your base system for setting up all other systems. Study metrics, global contracts \u2013 they all flow from your CTMS to other systems\u201d<br \/>\n<span>Bonne Adams, vice president of operations, Inhibrx Biosciences<\/span>\n<\/p><\/blockquote>\n<h2>Taking control: leveraging a CTMS for successful outsourced trials<\/h2>\n<p>Investing in an in-house CTMS helps sponsors improve: <\/p>\n<ul>\n<li><strong>Efficiency:<\/strong> Automate data transfers, optimize workflows, and collaborate on study execution. Manual data entry and extracts become a thing of the past, freeing sponsors to identify trends faster and focus on strategic initiatives.\n<li><strong>Visibility:<\/strong> Identify potential roadblocks early, adjust strategies on the fly, and make data-driven decisions that optimize trial success.\n<li><strong>Accuracy:<\/strong> Centralizing data minimizes the risk of errors, providing confidence in the integrity of trial data.\n<li><strong>Compliance:<\/strong> Alerts keep sponsors informed of upcoming deadlines and automatic document filing in eTMF ensures inspection readiness.\n<\/ul>\n<\/p>\n<div class=\"gray-box\" style=\"border-radius: 50px; background: #F1F3F6;padding-left:40px\">\n<div class=\"orange-line\">\n<h2 class=\"mt-15\">Oversight without overinvestment<\/h2>\n<p>Successful oversight is the result of harmonized people, processes, and technology. Technology supports both the data and processes, minimizing the effort required from people. For example:<\/p>\n<ul>\n<li>Automated data transfers maximize accuracy without manual intervention\n<li>Workflows ensure that accountable personnel comply with appropriate steps\n<li>Reports and dashboards provide an at-a-glance view of progress\n<li>When a threshold is crossed, alerts notify teams to take action\n<\/ul>\n<\/p>\n<p>Start with technology to ensure that data collection, process management, and reporting are handled well. With these foundational capabilities, oversight can become a positive opportunity rather than an expensive burden.<\/p>\n<\/div>\n<\/div>\n<p>The manager of clinical trial systems at a biotech that outsources 60% of its studies to CROs, started small when first implementing a CTMS. \u201cYour process should be really simple to start, and that\u2019s how you can scale up,\u201d he advises. \u201cWe started by having everyone write their oversight monitoring reports in ³Ô¹Ï±¬ÁÏ CTMS. Then, once they felt comfortable, we asked people to also put their KPIs in. Next, we moved on to risk management and more.\u201d<\/p>\n<p>The company\u2019s clinical team also uses CTMS Transfer to easily receive data from one of their CROs. This feature automates the daily transfer of study data from its CRO, providing the team with secure, read-only access to their trial data. \u201cWith CTMS Transfer, we maintain oversight and visibility while allowing the CRO to leverage its own ³Ô¹Ï±¬ÁÏ CTMS,\u201d says the manager of clinical trial systems. \u201cIt saves us significant time, effort, and costs associated with manual data uploads and reconciliation.\u201d <\/p>\n<blockquote><p>\n\u201cYour process should be really simple to start, and that\u2019s how you can scale up. We started by having everyone write their oversight monitoring reports in ³Ô¹Ï±¬ÁÏ CTMS. Then, once they felt comfortable, we asked people to also put their KPIs in. Next, we moved on to risk management and more.\u201d<br \/>\n<span>Manager of clinical trial systems at a late-stage biotech<\/span>\n<\/p><\/blockquote>\n<h2>Selecting the right CTMS<\/h2>\n<p>Clinical trials are dynamic, demanding flexibility and adaptability. Selecting the right CTMS is a crucial decision that can make or break the efficiency and success of your trials.<\/p>\n<p><strong>The power of scalability:<\/strong> Your organization\u2019s needs will evolve, so your CTMS should too. Look for a full-featured solution that addresses current requirements and accommodates future growth. Whether you handle trials in-house or outsource to CROs, a scalable CTMS ensures continued support regardless of operating model.<\/p>\n<p>Aileen Ilaria, vice president of clinical operations at New York-based biotech Immunovant suggests the &#8220;tipping point&#8221; for sponsors to bring their CTMS in-house is when trackers become unmanageable. For her team, this was around five or six trials going simultaneously, particularly Phase II and III studies. \u201cWe were looking forward to exponential portfolio growth while hitting the breaking point of what we could continue to do through trackers,\u201d she explains. \u201cWe couldn\u2019t make decisions quickly enough or properly allocate resources because we were working with week-old data.\u201d<\/p>\n<p>With an in-house CTMS, Ilaria\u2019s team has more real-time data to guide their decision-making than they did before. &#8220;As a lean team, having several trials going on simultaneously stretches your organization thin,&#8221; Ilaria notes, &#8220;Knowing where you need to put resources is key.&#8221;<\/p>\n<p><strong>Connected clinical ecosystem:<\/strong> The right CTMS acts as a central hub, facilitating seamless data exchange and fostering collaboration. It also connects with other key applications to automate activities such as document filing in eTMF and study personnel training based on protocol updates and milestones.\u00a0<\/p>\n<p>At <a href=\"https:\/\/www.clinicaltrialvanguard.com\/executiveinterviews\/embracing-technology-in-clinical-operations-a-conversation-with-bonne-adams-of-inhibrx\/\" target=\"_blank\" rel=\"noopener noreferrer\">Inhibrx<\/a>, Adams has seen the financial and time savings of having a connected platform. \u201cI\u2019ve looked at our budgets, and we save a lot of time and money by having connected solutions like ³Ô¹Ï±¬ÁÏ\u2019s. Plus, there\u2019s no redundancy anymore. The effort it takes to manage the systems goes down drastically,\u201d she explains. <\/p>\n<p><strong>Innovation is the engine of progress:<\/strong> Seek a CTMS from a forward-thinking provider with a commitment to continuous innovation. This commitment translates to a system that can adapt to changing regulations, industry best practices, and the ever-evolving needs of your clinical trials.<\/p>\n<div class=\"gray-box\" style=\"border-radius: 50px; background: #F1F3F6;padding-left:40px\">\n<div class=\"orange-line\">\n<h2 class=\"mt-15 mb-10\">Key CTMS capabilities<\/h2>\n<ul class=\"column-list\">\n<li>Maintain study roster<\/li>\n<li>Track investigator, vendor, and site information<\/li>\n<li>Manage study milestones<\/li>\n<li>Track enrollment<\/li>\n<li>Conduct monitoring oversight (MVR reviews)<\/li>\n<li>Manage issues and protocol deviations<\/li>\n<li>Document study oversight<\/li>\n<li>Collaborate on study execution<\/li>\n<li>Track trial trends and progress with real-time reports and dashboards<\/li>\n<li>Automate data transfer from CRO to sponsor systems<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"gray-box text-center\" style=\"margin-top:60px;margin-bottom:60px;border-radius: 60px; padding-top:40px;padding-bottom:40px;\nbackground: var(--Vibrant-Orange, linear-gradient(283deg, #F08A1B -18.01%, #FA6D18 78.17%));\"><\/p>\n<h2 class=\"mt-15 white mb-30\">The ³Ô¹Ï±¬ÁÏ CTMS difference<\/h2>\n<div class=\"row\">\n<div class=\"col-md-4\">\n<img decoding=\"async\" width=\"180\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2024\/06\/CTMS-icon-flexible@2x.png\" alt=\"\" \/><\/p>\n<h3 class=\"white mt-5 mb-5\">Flexible<\/h3>\n<p class=\"white mt-10\">Easily support different operating models and study-specific needs in one system.<\/p>\n<\/div>\n<div class=\"col-md-4\">\n<img decoding=\"async\" width=\"180\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2024\/06\/CTMS-icon-unified-and-connected@2x.png\" alt=\"\" \/><\/p>\n<h3 class=\"white mt-5 mb-5\">Unified and connected<\/h3>\n<p class=\"white mt-10\">Work seamlessly across data and documents and reduce integrations to drive cross-functional efficiencies.<\/p>\n<\/div>\n<div class=\"col-md-4\">\n<img decoding=\"async\" width=\"180\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2024\/06\/CTMS-icon-enhanced-analysis@2x.png\" alt=\"\" \/><\/p>\n<h3 class=\"white mt-5 mb-5\">Enhanced analysis and insights<\/h3>\n<p class=\"white mt-10\">Interactive dashboards allow users to move directly from insight to action to optimize trial performance.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<blockquote><p>\n \u201cHaving a validated system like ³Ô¹Ï±¬ÁÏ CTMS is much better for scalability and repeatability. It is so much easier to run reports and have top-level oversight.\u201d<br \/>\n<span>Manager of clinical trial systems at a late-stage biotech<\/span>\n<\/p><\/blockquote>\n<div class=\"gray-box\" style=\"border-radius: 50px; background: #F0F7FF;padding:60px;text-align:center\">\n<h2 style=\"margin-top:0px;font-weight:300\">Clinical trials are the engine for growth and innovation. With the right tools and strategies in place when outsourcing, you can bring life-changing treatments to patients faster and more efficiently, fulfilling the true promise of clinical research.<\/h2>\n<h2 style=\"font-weight:300\">See how to gain visibility, increase efficiency, and standardize reporting processes for outsourced studies through ³Ô¹Ï±¬ÁÏ CTMS.<\/h2>\n<p><a href=\"\/eu\/products\/veeva-ctms\/transfer\/\" class=\"buttons orange mb-0\">Read More<\/a>\n<\/div>\n<p><footnotes><\/p>\n<hr>\n<p><sup>1.<\/sup>\u00a02022. McKinsey &#038; Company. CROs and biotech companies: Fine-tuning the partnership.<br \/>\n<\/footnotes><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Are you maximizing efficiency and reducing trial timelines? Whether you manage trials in-house or outsource, having a robust CTMS is key to effective execution.<\/p>\n","protected":false},"featured_media":0,"parent":0,"template":"","class_list":["post-78247","resources","type-resources","status-publish","hentry","search-do-not-search","resource-do-not-display-do-not-display","resource-area-20-clinical-operations","resource-product-20-ctms","resource-type-ebooks"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/78247"}],"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":1,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/78247\/revisions"}],"predecessor-version":[{"id":82890,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/78247\/revisions\/82890"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=78247"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}