{"id":97462,"date":"2026-05-18T19:50:44","date_gmt":"2026-05-18T17:50:44","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?page_id=97462"},"modified":"2026-05-18T21:11:58","modified_gmt":"2026-05-18T19:11:58","slug":"tmf-trend-report-2026","status":"publish","type":"page","link":"https:\/\/www.veeva.com\/eu\/tmf-trend-report-2026\/","title":{"rendered":"4 Trends Driving TMF Strategy in the Age of AI"},"content":{"rendered":"<style>\n<p>.product-container a {\n \tfont-weight:500;\n}<\/p>\n<p>p.font-20 {\n\tfont-size:20px;\n\tline-height:28px;\n}\nimg.trends {\n\tborder-radius: 20px;\n\tbox-shadow: 4px 6px 25px 0px rgba(0, 0, 0, 0.08);\n\tmargin:12px;\n\twidth: 160px;\n}\nimg.trends:hover {\n\tborder-radius: 20px;\n\tbox-shadow: 4px 6px 25px 0px rgba(0, 0, 0, .16);\n}<\/p>\n<p>@media only screen and (min-width : 1200px) {\n.product-container\t.container {\n\t\twidth: 100%;\n\t\tmax-width: 1140px;\n\t}\n}<\/p>\n<p>@media only screen and (min-width : 1280px) {\n.product-container\t.container {\n\t\twidth: 100%;\n\t\tmax-width: 1180px;\n\t}\n}<\/p>\n<p>@media only screen and (min-width : 1400px) {\n.product-container\t.container {\n\t\twidth: 100%;\n\t\tmax-width: 1340px;\n\t}\n}<\/p>\n<p>ol.tmf-num  {\n\tcounter-reset: list;\n\tlist-style: none;\n\tmargin-left:25px;\n}\nol.tmf-num li {\n\tcounter-increment: list;\n\tposition: relative;\n}<\/p>\n<p>ol.tmf-num li:before {\n  \tcontent: \" \";\n  \tmargin-right: 25px;\n  \tposition: absolute;\n  \tright: 100%;\n  \tfont-size:38px;\n\tcolor:#1A76A3;\n\tfont-weight:500;\n\tmargin-top:10px;\n}\nol.tmf-num li.count1:before {\n  \tcontent: \"1\";\n}\nol.tmf-num li.count2:before {\n  \tcontent: \"2\";\n}\nol.tmf-num li.count3:before {\n  \tcontent: \"3\";\n}\nol.tmf-num li.count4:before {\n  \tcontent: \"4\";\n}\n@media screen and (max-width: 991px) {\n\tol.tmf-num  {\n\t   margin-bottom:30px;\n\t}\n\tol.tmf-num li:before {\n\t\tmargin-right: 20px;\n\t\tfont-size:36px;\n\t\tmargin-top:8px;\n\t}\n}\n@media screen and (max-width: 767px) {\n\tol.tmf-num li:before {\n\t\tmargin-right: 15px;\n\t\tfont-size:32px;\n\t}\n}<\/p>\n<p>.button-default.secondary.white:hover, a.button-default.secondary.white:hover {\n\tbackground:#FF6B00;\n}<\/p>\n<p>.white-on-orange-link {\n\tcolor: white;\n\ttext-decoration: underline;\n}<\/p>\n<p>.white-on-orange-link:focus,\n.white-on-orange-link:hover {\n\tcolor:white;\n\ttext-decoration: none;\n}<\/p>\n<\/style>\n<div class=\"single-hero\"  style=\"background-image: url('https:\/\/www.veeva.com\/wp-content\/uploads\/2024\/05\/bg-hero_2x.png');\">\n<div class=\"container\">\n<div class=\"row flex-align text-center\">\n<div class=\"col-sm-12 col-centered \">\n<h1 class=\"mt-20\" style=\"font-weight:300;line-height:1.1em;\">4 Trends Driving TMF Strategy <br class=\"visible-lg\">in the Age of AI<\/h1>\n<p>\t\t\t\t<a href=\"https:\/\/www.veeva.com\/eu\/wp-content\/uploads\/2026\/05\/4-Trends-Driving-TMF-Strategy-in-the-Age-of-AI-EU.pdf\" target=\"_blank\" class=\"button-default secondary white mb-10\" rel=\"noopener\">Download PDF<\/a><\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<div class=\"product-container\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-md-9 col-centered text-center\">\n<p class=\"strong font-20\">TMF leaders connected at the Veeva TMF Innovation Forum to discuss how to implement AI as a validated, auditable step in the TMF workflow. These advancements will redefine every aspect of TMF operations, from team roles to quality control and oversight.<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"row mt-40\">\n<div class=\"col-md-12\" style=\"padding:0px\">\n<h2 class=\"mb-40\">Here are four TMF trends and how they will impact your teams:<\/h2>\n<p>\t\t\t\t<a class=\"quicklink\" href=\"#autonomous-tmf\"><img decoding=\"async\" class=\"trends\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2026\/05\/Autonomous-TMF-button@2x.png\" alt=\"autonomous tmf icon\" \/><\/a><br \/>\n\t\t\t\t<a class=\"quicklink\"  href=\"#evolving-roles\"><img decoding=\"async\" class=\"trends\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2026\/05\/Evolving-roles-button@2x.png\" alt=\"evolving roles icon\" \/><\/a><br \/>\n\t\t\t\t<a class=\"quicklink\" href=\"#risk-based-qc\"><img decoding=\"async\" class=\"trends\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2026\/05\/Risk-based-QC-button@2x.png\" alt=\"risb-based qx icon\" \/><\/a><br \/>\n\t\t\t\t<a class=\"quicklink\" href=\"#collaborative-partnerships\"><img decoding=\"async\" class=\"trends\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2026\/05\/Collaborative-partnerships-button@2x.png\" alt=\"collaborative partnerships icon\" \/><\/a>\n        \t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<div style=\"position:relative;\">\n  <a id=\"autonomous-tmf\" style=\"position: absolute;top: -100px;\"><\/a>\n<\/div>\n<div class=\"product-container\" style=\"background:#f9f9f9\">\n<div class=\"container\">\n<div class=\"row text-left\">\n<div class=\"col-md-7 col-lg-8\">\n<ol class=\"tmf-num\">\n<li class=\"count1\">\n<h2 class=\"title\">The TMF is transitioning from active to autonomous<\/h2>\n<p> For years, TMF leaders advocated for active TMF, a model where the TMF is a place to do your work rather than a passive, post-hoc archive. Now, with the introduction of agentic AI, TMF management will evolve from &#8220;active&#8221; to &#8220;autonomous.&#8221;<\/p>\n<p>However, autonomous TMF is not a replacement for the active TMF model. Autonomous TMF is built upon a foundation of active TMF workflows, document viewers, and reporting structures. In this evolution, these components transition from human-operated tools into the core infrastructure for AI agents.<\/p>\n<p>But an autonomous system is only as good as the data it consumes. A <em>master consumer model<\/em> prevents &#8220;automated chaos&#8221; by automatically pulling the truth from across the trial ecosystem and establishing a standard of data integrity.<\/p>\n<p>By creating connections across clinical operations, autonomous TMF detects risks, such as a mismatch between a subject\u2019s age and an assent form, and automatically triggers remediation tasks for the site. Compliance issues resolve at the source before they become audit findings.<\/p>\n<p>TMF leaders expect a majority of TMF activities to be autonomous within the next three years. This will free up TMF teams to become \u201cprocess architects\u201d focused on strategic oversight and approvals. It will also transform roles across the business, including CRAs.<\/p>\n<p>\u201cI\u2019m well aware of the burdens that a CRA has when they\u2019re on site,\u201d says one head of TMF at a top 10 biopharma. \u201cWith regard to the TMF, the activities that require most of a CRA&#8217;s time on site are comparing the ISF to the TMF and ensuring all the proper records have been collected. If agents manage those aspects and prompt CRAs ahead of site visits with what they\u2019re missing, we\u2019ll see big time savings and improved relationships.\u201d<\/p>\n<\/li>\n<\/ol><\/div>\n<div class=\"col-md-5 col-lg-4\">\n        \t<img decoding=\"async\" class=\"img-responsive mt-15\" style=\"max-width:400px;\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2026\/05\/Trend-1-graphic@2x.png\" alt=\"path to autonomous tmf graph\" \/>\n        \t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<div style=\"position:relative;\">\n  <a id=\"evolving-roles\" style=\"position: absolute;top: -100px;\"><\/a>\n<\/div>\n<div class=\"product-container\">\n<div class=\"container\">\n<div class=\"row text-left\">\n<div class=\"col-md-12 col-lg-12\">\n<ol class=\"tmf-num\">\n<li class=\"count2\">\n<h2 class=\"title\">TMF leads are evolving from processors to process architects<\/h2>\n<p>TMF leads have long been bogged down by administrative tasks like inbox triage and manual filing. Now, AI agents are fundamentally changing these roles. Instead of executing tasks, TMF leads will focus on managing AI-driven workflows and enabling strategic oversight.<\/p>\n<p>TMF leads only need to intervene when the application flags an event that requires human judgment. This change allows TMF leads to focus more on strategic outcomes and human-in-the-loop validation.<\/p>\n<p>\u201cBeyond metadata extraction and QC, AI will be able to report on study milestones with country intelligence,\u201d says the head of TMF at one top 20 biopharma. \u201cAI will identify the relationships between events, what records are expected, and what needs to be packaged for other business units.\u201d<\/p>\n<\/li>\n<\/ol><\/div>\n<div class=\"col-md-12 col-lg-12\">\n        \t<img decoding=\"async\" class=\"img-responsive mt-15\" style=\"max-width:800px;\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2026\/05\/Trend-2-Table@2x.png\" alt=\"the sift in TMF operations table\" \/>\n        \t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<div style=\"position:relative;\">\n  <a id=\"risk-based-qc\" style=\"position: absolute;top: -100px;\"><\/a>\n<\/div>\n<div class=\"product-container\" style=\"background:#f9f9f9\">\n<div class=\"container\">\n<div class=\"row text-left\">\n<div class=\"col-md-7 col-lg-8\">\n<ol class=\"tmf-num\">\n<li class=\"count3\">\n<h2 class=\"title\">Biopharmas are embracing risk-based quality control<\/h2>\n<p>Last year, CDISC published their <a href=\"https:\/\/www.cdisc.org\/sites\/default\/files\/2025-06\/2025-05-30_TMF_Risk_Initiative_White_Paper_v1.2_0.pdf\" target=\"_blank\" rel=\"noopener\">TMF Risk Management White Paper<\/a> to advocate for risk-based quality management (RBQM) to improve data quality and inspection readiness. This guideline coupled with the MHRA&#8217;s recently published <a href=\"https:\/\/www.veeva.com\/eu\/resources\/ich-gcp-e6r3-implications-on-fully-outsourced-sponsors-and-studies\/\">ICH E6(R3)<\/a> is a signal for TMF leaders: 2026 is the time to adopt risk-based quality control (QC).<\/p>\n<p>Key principles, as highlighted by CDISC and industry guidance, include:<\/p>\n<ul>\n<li><strong>Risk proportionality:<\/strong> The need to move beyond a &#8220;one size fits all&#8221; QC approach, recognizing that risk is multifactorial and contingent on trial design, technology, and operating models<\/li>\n<li><strong>Criticality focus:<\/strong> Baseline TMF controls should be modified based on the potential threats to patient rights, data integrity, and document &#8220;essentiality.&#8221; This means focusing on elements critical to trial quality<\/li>\n<li><strong>ALCOA+ principles:<\/strong> Risk-based QC must ensure that essential records consistently meet the data integrity standards of Attributable, Legible, Contemporaneous, Original, Accurate, and Complete (ALCOA+).<\/li>\n<\/ul>\n<p>Embracing risk-based QC shifts the burden from a manual, high-volume process to a targeted, automated process \u2013 ultimately removing the reliance on manual spreadsheets. In practice, this can look like:<\/p>\n<ul>\n<li><strong>Document type risk mapping:<\/strong> Organizations can associate specific document types to a pre-defined QC risk level (e.g., high, medium, low).<\/li>\n<li><strong>QC risk rules:<\/strong> TMF teams can create rules to define a sampling percentage for each risk level.<\/li>\n<li><strong>Automated risk assessment:<\/strong> TMF leads can create an eTMF workflow that automatically executes a risk assessment when a document enters QC.<\/li>\n<\/ul>\n<\/li>\n<\/ol><\/div>\n<div class=\"col-md-5 col-lg-4\">\n        \t    <img decoding=\"async\" class=\"img-responsive mt-15\" style=\"max-width:400px;\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2026\/05\/Trend-3-graphic@2x.png\" alt=\"embracing risk-based QC\" \/>\n        \t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<div style=\"position:relative;\">\n  <a id=\"collaborative-partnerships\" style=\"position: absolute;top: -100px;\"><\/a>\n<\/div>\n<div class=\"product-container\">\n<div class=\"container\">\n<div class=\"row text-left\">\n<div class=\"col-md-7 col-lg-8\">\n<ol class=\"tmf-num\">\n<li class=\"count4\">\n<h2 class=\"title\">Companies are pivoting toward continuous AI-driven compliance<\/h2>\n<p>AI is changing both inspection preparation and execution. For example, one biopharma shared they have an upcoming MHRA inspection, and the dossier includes how the company qualifies and uses AI tools.<\/p>\n<p>Because the FDA will have <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-expands-artificial-intelligence-capabilities-agentic-ai-deployment#:~:text=In%20this%20section-,Press%20Announcements,more%20cures%20and%20meaningful%20treatments.%E2%80%9D\" target=\"_blank\" rel=\"noopener\">the tools<\/a> to look at everything simultaneously, biopharmas are shifting their strategies from passing visual checks to maintaining continuous, machine-readable data integrity.<\/p>\n<p>Some TMF leaders are looking toward AI to help them maintain inspection readiness. One biopharma shared the example of a safety management plan that notes monthly meetings. AI could review this record and then flag that monthly meeting minutes are missing from the TMF.<\/p>\n<p>Ultimately, the future of regulatory inspections will not be about inspectors sitting in conference rooms requesting individual PDFs. It will be defined by seamless interoperability, structured data, and artificial intelligence.<\/p>\n<\/li>\n<\/ol><\/div>\n<div class=\"col-md-5 col-lg-4\">\n        \t    <img decoding=\"async\" class=\"img-responsive mt-15\" style=\"max-width:400px;\" src=\"https:\/\/www.veeva.com\/wp-content\/uploads\/2026\/05\/Trend-4-graphic@2x.png\" alt=\"the futrure of regulatory inspections\" \/>\n        \t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<div class=\"product-container cover\" style=\"padding:30px;background-image: url('\/wp-content\/uploads\/2024\/05\/bg-footer-cta_2x.png');\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-md-12\">\n<h2 class=\"white mb-15\">Continue the Discussion at Veeva Summit<\/h2>\n<p class=\"white mb-30\">\n\t\t\t\tTo continue the discussion with TMF leaders on improving trial efficiency and inspection readiness, <br class=\"visible-md visible-lg\">register for <a class=\"white-on-orange-link\" target=\"_blank\" rel=\"noopener\" href=\"\/eu\/events\/rd-summit\/overview\/\">Veeva R&#038;D and Quality Summit<\/a> in Copenhagen on October 28-29 May.<\/p>\n<p>\t\t\t\t<a href=\"\/eu\/events\/rd-summit\/register\/\" target=\"_blank\" rel=\"noopener\" class=\"button-default secondary white mb-10\">Register Now<\/a>\n        \t<\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>From active to autonomous TMF, biopharma TMF leaders share how artificial intelligence advances TMF strategy.<\/p>\n","protected":false},"author":131,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/template-full-page.php","meta":{"footnotes":""},"coauthors":[1705],"class_list":["post-97462","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/pages\/97462"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/users\/131"}],"replies":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/comments?post=97462"}],"version-history":[{"count":4,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/pages\/97462\/revisions"}],"predecessor-version":[{"id":97480,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/pages\/97462\/revisions\/97480"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=97462"}],"wp:term":[{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/coauthors?post=97462"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}