{"id":81046,"date":"2024-12-13T13:30:16","date_gmt":"2024-12-13T12:30:16","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?p=81046"},"modified":"2026-06-11T16:23:22","modified_gmt":"2026-06-11T14:23:22","slug":"2025-rd-and-quality-predictions-process-excellence-removes-barriers-speeds-connections","status":"publish","type":"post","link":"https:\/\/www.veeva.com\/eu\/blog\/2025-rd-and-quality-predictions-process-excellence-removes-barriers-speeds-connections\/","title":{"rendered":"2025 R&#038;D and Quality Predictions: Process Excellence Removes Barriers, Speeds Connections"},"content":{"rendered":"<style>\n\t.blog-single-content hr {\n\t\tmargin: 10px 0 15px 0;\n\t}<\/p>\n<p>\t.blog-single-content img {\n\t\tpadding: 0 20px;\n\t\tmargin: 44px 0 0;\n\t}\n<\/style>\n<div class=\"blog-wrap\" style=\"position:relative;\">\n<div class=\"row\">\n<div class=\"col-xs-12\">\n<p class=\"hero-blog-copy\">\nConnected systems and unified data drive faster, safer, and more efficient drug development across R&#038;D and quality teams. In the coming year, biopharmas will focus on process excellence to overcome legacy bottlenecks, from improving clinical trials for patients and sites to unifying QA and QC. Here are eight predictions for 2025 from Veeva\u2019s R&#038;D and quality experts.\n<\/p>\n<p>\n\t\t<\/div>\n<\/p><\/div>\n<hr>\n<div class=\"row\">\n<div id=\"1\" class=\"anchor\"><\/div>\n<div class=\"col-xs-12 col-md-4 text-center\">\n\t\t\t<img decoding=\"async\" src=\"\/wp-content\/uploads\/2023\/12\/Jim-Reilly.png\" alt=\"Paul Shawah\" style=\"border:none;max-width:200px;margin-bottom:10px\"><\/p>\n<p><strong>&mdash; Jim Reilly, Executive Vice President, R&#038;D Strategy<\/strong><\/p>\n<\/p><\/div>\n<p><\/p>\n<div class=\"col-xs-12 col-md-8\">\n<h2>Process excellence will speed content and data flow across R&#038;D<\/h2>\n<p>Today, a simple and vital task like turning adverse events in EDC into <a href=\"\/eu\/resources\/safety-edc-connection-demo\/\">safety cases<\/a> can run the gamut, from being an automated workflow at one company to requiring hours of manual effort across disparate systems at another. These inconsistencies slow drug development, and patients ultimately bear that burden. In 2025, biopharmas will focus on <a href=\"https:\/\/www.cio.com\/article\/465214\/industry-clouds-prove-their-business-value.html\" target=\"_blank\" rel=\"noopener noreferrer\">process excellence<\/a> to improve the flow of content and data across R&#038;D.<\/p>\n<p>Now that sponsors are seeing the limits of disconnected, best-of-breed solutions, the industry is ready to standardize and simplify. This will be driven by investments in process standards across R&#038;D. Some companies may focus on workflow automation to improve the flow of content and data across clinical, regulatory, safety, and quality. Others may rethink the way their organizations are structured to create dedicated process excellence teams.<\/p>\n<\/p>\n<\/div><\/div>\n<hr>\n<div class=\"row\">\n<div id=\"2\" class=\"anchor\"><\/div>\n<div class=\"col-xs-12 col-md-4 text-center\">\n\t\t\t<img decoding=\"async\" src=\"\/eu\/wp-content\/uploads\/2024\/12\/Drew-Garty.png\" alt=\"Dan Rizzo\" style=\"border:none;max-width:200px;margin-bottom:10px\"><\/p>\n<p><strong>&mdash; Drew Garty, Chief Technology Officer, Clinical Data<\/strong><\/p>\n<\/p><\/div>\n<p><\/p>\n<div class=\"col-xs-12 col-md-8\">\n<h2>Underrepresented trial populations will get more choice<\/h2>\n<p>Patient enrollment and retention continue to challenge sites and sponsors, with <a href=\"https:\/\/www.medistrava.com\/insights\/recruitment-and-retention-trends-in-clinical-trials-in-2024\/\" target=\"_blank\" rel=\"noopener noreferrer\">trial complexity and patient fatigue<\/a> contributing to high dropout rates. In 2025, sponsors that give patients <a href=\"\/eu\/blog\/patient-centric-clinical-trials-the-power-of-choice\/\">more options<\/a> for onboarding and trial visits will improve their experience and expand the participant pool to previously underserved populations. <\/p>\n<p>New FDA draft guidance on Diversity Action Plans urges sponsors to enroll more diverse patients and show the statistical breakdown of these groups in their trials. This will affect how data is processed and analyzed for submissions, to ensure enough clean data is available to meet statistical endpoints for each demographic subgroup.<\/p>\n<p>More patient options mean more data inputs and complexity. From monitoring subgroup enrollment and retention to data management and statistical analysis, unified data at the center will enable patient participation at the edges.<\/p>\n<\/p>\n<\/div><\/div>\n<hr>\n<div class=\"row\">\n<div id=\"3\" class=\"anchor\"><\/div>\n<div class=\"col-xs-12 col-md-4 text-center\">\n\t\t\t<img decoding=\"async\" src=\"\/eu\/wp-content\/uploads\/2024\/12\/Bree-Burks.png\" alt=\"Bree Burks\" style=\"border:none;max-width:200px;margin-bottom:10px\"><\/p>\n<p><strong>&mdash; Bree Burks, Vice President, Site Strategy<\/strong><\/p>\n<\/p><\/div>\n<p><\/p>\n<div class=\"col-xs-12 col-md-8\">\n<h2>Sponsors will step up to solve site capacity issues<\/h2>\n<p>Clinical research sites are the backbone of drug development. But, as the number of global clinical trials increases, the clinical site workforce is decreasing with <a href=\"https:\/\/www.jctres.com\/media\/downloads\/jctr2400022\/%5B4%5D%20JCTR_v10i4_003%20-%20Proof%205.0%20(finalized).pdf\" target=\"_blank\" rel=\"noopener noreferrer\">high staff turnover rates<\/a>. Complex protocols with multiple amendments and too many sponsor technologies per study are pulling site staff away from patients, limiting their capacity to take on more trials.<\/p>\n<p>As sponsors rethink their site engagement strategies in 2025, they will prioritize consistent site technology and standardization across sponsors for all trials. With <a href=\"https:\/\/myscrs.org\/learning-campus\/white-papers\/\" target=\"_blank\" rel=\"noopener noreferrer\">55% of sites<\/a> reporting that their top challenge is supporting a variety of technologies, sponsors will drive standardization to avoid major slowdowns in their pipelines. <\/p>\n<p>The less time sites spend doing administrative work in systems, the more time they have to execute trials and help patients. This shift will help sites rebuild their capacity and ensure that drug development doesn\u2019t stall. <\/p>\n<\/p>\n<\/div><\/div>\n<hr>\n<div class=\"row\">\n<div id=\"4\" class=\"anchor\"><\/div>\n<div class=\"col-xs-12 col-md-4 text-center\">\n\t\t\t<img decoding=\"async\" src=\"\/eu\/wp-content\/uploads\/2024\/12\/Paul_Attridge.png\" alt=\"Paul Attridge\" style=\"border:none;max-width:200px;margin-bottom:10px\"><\/p>\n<p><strong>&mdash; Paul Attridge, Vice President, Vault RIM, Europe<\/strong><\/p>\n<\/p><\/div>\n<p><\/p>\n<div class=\"col-xs-12 col-md-8\">\n<h2>Health authorities will speed submissions with common data <\/h2>\n<p>While regulatory teams have been <a href=\"\/customer-stories\/real-time-submissions-publishing-reduces-nda-timeline\/\" target=\"_blank\" rel=\"noopener noreferrer\">streamlining the submissions process<\/a> with regulatory data offices and data stewardship, health authority (HA) approvals remain stubbornly labor-intensive. Inefficiencies in the process like similar questions submitted by different HAs at different times and in different languages create serious risks and contribute to a global duplication of effort. <\/p>\n<p>In the coming years, industry-wide initiatives will establish regulatory reliance pathways &mdash; agreements between multiple HAs to streamline common submission and review processes. Global access to common submission data and Q&#038;As will lead to <a href=\"\/eu\/resources\/accelerate-submission-preparation-with-vault-submissions-publishing\/\">faster submissions, better collaboration, and increased efficiencies<\/a> for sponsors and HAs. These initiatives will need to be carefully balanced to ensure safety, compliance, and the integrity of the local decision-making authority. <\/p>\n<\/p>\n<\/div><\/div>\n<hr>\n<div class=\"row\">\n<div id=\"5\" class=\"anchor\"><\/div>\n<div class=\"col-xs-12 col-md-4 text-center\">\n\t\t\t<img decoding=\"async\" src=\"\/eu\/wp-content\/uploads\/2024\/12\/Ashley-McMillan.png\" alt=\"Ashley McMillan\" style=\"border:none;max-width:200px;margin-bottom:10px\"><\/p>\n<p><strong>&mdash; Ashley McMillan, Senior Director, Vault LIMS Strategy<\/strong><\/p>\n<\/p><\/div>\n<p><\/p>\n<div class=\"col-xs-12 col-md-8\">\n<h2>QA and QC will unify to eliminate bottlenecks<\/h2>\n<p>Although quality assurance (QA) and quality control (QC) business processes are connected, the legacy systems underpinning them are not. To address this challenge, <a href=\"https:\/\/clarkstonconsulting.com\/insights\/2024-lims-trends\/\" target=\"_blank\" rel=\"noopener noreferrer\">leading companies are connecting QA, QC, and partners through a common technology<\/a>. In 2025, this investment in digital quality will shorten testing time and accelerate time to market.<\/p>\n<p>Quality organizations will unify their data and applications to significantly advance their reporting and analytics. This will deliver metrics to proactively manage risks and identify and address bottlenecks early. For example, having QA and QC data available at the batch decision point will result in faster batch release. Working from a single source of data will standardize collaboration with partners, eliminating manual work and the risk of data errors.<\/p>\n<p><a href=\"\/eu\/resources\/are-these-5-misconceptions-keeping-you-from-modernizing-qc\/\">Automating labor-intensive tasks<\/a> before commercializing will help early-stage companies scale with cost efficiencies. By bringing QA and QC together, biopharmas will establish the foundation for impactful AI use cases in years to come.<\/p>\n<\/p>\n<\/div><\/div>\n<hr>\n<div class=\"row\">\n<div id=\"6\" class=\"anchor\"><\/div>\n<div class=\"col-xs-12 col-md-4 text-center\">\n\t\t\t<img decoding=\"async\" src=\"\/wp-content\/uploads\/2023\/12\/Stephan-Ohnmacht.png\" alt=\"Stephan Ohnmacht\" style=\"border:none;max-width:200px;margin-bottom:10px\"><\/p>\n<p><strong>&mdash; Stephan Ohnmacht, Vice President, R&#038;D Business Consulting<\/strong><\/p>\n<\/p><\/div>\n<p><\/p>\n<div class=\"col-xs-12 col-md-8\">\n<h2>CRO data transparency will improve trial success<\/h2>\n<p>In 2025, sponsors will prioritize contract research organizations (CROs) offering full and continuous data transparency so they can start deriving insights immediately. As they <a href=\"\/eu\/customer-stories\/simplifying-to-speed-up-time-to-patient\/\">pursue end-to-end data ownership<\/a>, there will be a notable shift in dynamics when outsourcing. <\/p>\n<p>Sponsors and their chosen partners will start sharing data more fluidly across their systems: for example, to inform protocol design, onboard additional sites, identify potential rare disease participants, and move study endpoints. With access to live data as the new baseline, clinical development stakeholders will be more responsive to study changes. This can improve the probability of the trial succeeding and potentially reduce the time to get new medicines to patients.<\/p>\n<p>Emerging biotechs, sometimes fully outsourced, will benefit from improved oversight and be able to make decisions more nimbly. Data transparency will create greater trust, where sponsors of all sizes can collaborate with their CRO partners efficiently.<\/p>\n<\/div><\/div>\n<hr>\n<div class=\"row\">\n<div id=\"7\" class=\"anchor\"><\/div>\n<div class=\"col-xs-12 col-md-4 text-center\">\n\t\t\t<img decoding=\"async\" src=\"\/wp-content\/uploads\/2023\/12\/John-Lawrie.png\" alt=\"John Lawrie\" style=\"border:none;max-width:200px;margin-bottom:10px\"><\/p>\n<p><strong>&mdash; John Lawrie, Vice President, Vault Safety<\/strong><\/p>\n<\/p><\/div>\n<p><\/p>\n<div class=\"col-xs-12 col-md-8\">\n<h2>Comprehensive and reliable safety data will fuel advanced automation<\/h2>\n<p>Safety professionals continue to wrestle with an age-old question: how to handle growing data volumes with fewer resources while maintaining high quality. AI holds promise to do more with less, but inconsistent and disconnected data creates risk.<\/p>\n<p>To effectively support AI, safety teams will strengthen their data foundations with standardized, end-to-end pharmacovigilance processes. Cross-functional workflows will eliminate manual data transfers and provide clear data traceability back to the source. By simplifying and standardizing their systems landscape, companies will lay the <a href=\"\/eu\/blog\/building-a-safety-intelligence-unit-from-the-ground-up\/\">groundwork<\/a> for accelerating automation and AI innovation.<\/p>\n<p>This <a href=\"\/eu\/customer-stories\/streamlining-processes-with-unified-and-connected-safety\/\">end-to-end data flow<\/a> also opens the door for improved collaboration across organizations. For example, processes like timely reporting of SAEs from clinical EDC systems to safety can be done automatically with more complete data.<\/p>\n<\/div><\/div>\n<hr>\n<div class=\"row\">\n<div id=\"8\" class=\"anchor\"><\/div>\n<div class=\"col-xs-12 col-md-4 text-center\">\n\t\t\t<img decoding=\"async\" src=\"\/eu\/wp-content\/uploads\/2024\/12\/Seth-Goldenberg@2x.png\" alt=\"Seth Goldenberg\" style=\"border:none;max-width:200px;margin-bottom:10px\"><\/p>\n<p><strong>&mdash; Seth Goldenberg, Vice President, Vault MedTech<\/strong><\/p>\n<\/p><\/div>\n<p><\/p>\n<div class=\"col-xs-12 col-md-8\">\n<h2>Continuous AI\/ML devices will hit a new milestone<\/h2>\n<p>As of October 2024, the FDA has approved over <a href=\"https:\/\/www.biopharmadive.com\/news\/fda-ai-medical-devices-growth\/729444\/?utm_source=Sailthru&#038;utm_medium=email&#038;utm_campaign=Issue:%202024-10-10%20BioPharma%20Dive%20%5Bissue:66683%5D&#038;utm_term=BioPharma%20Dive\" target=\"_blank\" rel=\"noopener noreferrer\">950 AI\/ML-enabled medical devices<\/a>. However, these approvals have been for \u2018<a href=\"https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/software-medical-device-samd\" target=\"_blank\" rel=\"noopener noreferrer\">software-as-a-medical device<\/a>\u2019 (SaMD) that use \u2018passive\u2019 ML to train products. After the product is trained to process data sets and identify trends, it is locked down and no longer uses ML.<\/p>\n<p>In 2025, we will see the first-ever new product submission for a medical device enabled by continuous ML. This device will take things a step further than an SaMD, addressing patient needs faster and more effectively. Rather than simply being trained using ML, the device will change as it is exposed to more patient data. Following FDA&#8217;s <a href=\"https:\/\/www.medtechdive.com\/news\/fda-final-guidance-predetermined-change-control-plans-ai\/734608\/\" target=\"_blank\" rel=\"noopener noreferrer\">final guidance on postmarket updates<\/a>, this will enable <a href=\"https:\/\/www.imdrf.org\/sites\/default\/files\/2022-05\/IMDRF%20AIMD%20WG%20Final%20Document%20N67.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">continuous learning<\/a> during the device\u2019s operational life cycle to help it actively respond to patient needs.<\/p>\n<p>This submission will likely come from a key domain like radiology or neuromodulation, where medtech companies typically have the necessary quantities of clinical data to train AI\/ML models. An example can look like a neurostimulator implant or a combination of continuous glucose monitoring and insulin delivery tech that automatically adjust to meet a patient&#8217;s dosage needs without physician intervention.<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A focus on process excellence across R&#038;D and quality will overcome legacy bottlenecks, from improving the clinical trials for patients and sites to unifying QA and QC. 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