{"id":5884,"date":"2025-03-14T13:56:16","date_gmt":"2025-03-14T13:56:16","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=5884"},"modified":"2025-04-17T19:28:00","modified_gmt":"2025-04-17T18:28:00","slug":"clinical-trial-monitoring","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/clinical-trial-monitoring\/","title":{"rendered":"Clinical Trial Monitoring"},"content":{"rendered":"\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-clinical-trial-monitoring-team\"><strong>Clinical Trial Monitoring Team<\/strong><\/h2>\n\n\n\n<p><strong>Experienced Team<\/strong><\/p>\n\n\n\n<p>Almac Diagnostic Services has a dedicated Global Clinical Trial Monitoring Team, experienced in Monitoring Clinical Device Trials globally. Our team ensure effective and efficient Clinical Trial Device Monitoring across a range of diverse diagnostic device technologies (such as qPCR, NGS, NanoString, IHC, ELISA).<\/p>\n\n\n\n<p><strong>Independent Analysis<\/strong><\/p>\n\n\n\n<p>The Global Clinical Trial Monitoring Team are independent from our Clinical Device Trial Delivery and Clinical Testing teams; and report directly to Almac Diagnostic Services Global VP &amp; Medical Director, enabling rapid decision making &amp; resolution.<\/p>\n\n\n\n<p><strong>Qualifications &amp; Language Proficiency<\/strong> <\/p>\n\n\n\n<p>Many of our team hold PhD academic qualifications in areas relevant to Diagnostic Devices, to ensure compliant and effective Clinical Device Trial Monitoring. Additionally, Almac employ native language speakers (Mandarin, Cantonese, etc.) to support the specific challenges in Device Trial delivery and Device Trial Monitoring in China.<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-trial-monitoring-service\" style=\"font-size:20px\"><strong>Clinical Trial Monitoring<\/strong> <strong>Service<\/strong><\/h2>\n\n\n\n<p>Global Clinical Trial Monitoring confirms Clinical Device Trials are conducted in adherence with ICH Good Clinical Practice (GCP), applicable regulatory requirements (e.g. Clinical Performance Study Plan (CPSP), Investigational Device Exemption (IDE), In Vitro Medical Devices Regulation (IVDR), and other specific client requirements. Furthermore, it enables alignment of Clinical Device Trial delivery globally ensuring patient safety and data integrity, while also supporting future product approvals.<\/p>\n\n\n\n<p>Almac Diagnostic Services has rigorous monitoring procedures established which meet global regulatory requirements (ICH GCP, IVDR, ISO 20916, IDE, &amp; Human Genetic Resources Regulation) throughout the trial duration; guaranteeing effective, efficient, and compliant visits are conducted, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Site Initiation Visits (SIVs)<\/li>\n\n\n\n<li>Interim Site Monitoring Visits (SMVs)<\/li>\n\n\n\n<li>Site Closeout Visits (SCVs)<\/li>\n<\/ul>\n\n\n\n<p>Our monitoring strategies are flexible and risk based enabling us to meet client and clinical device trial requirements.&nbsp; We can adjust the frequency of SMVs and the depth of Source Data Verification (SDV) as necessary, while maintaining patient safety and data integrity.<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-core-areas-audited-during-site-visits\" style=\"font-size:20px\"><strong>Core Areas Audited During Site Visits<\/strong><\/h2>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"903\" height=\"638\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring.png\" alt=\"\" class=\"wp-image-5910 lazyload\" style=\"--smush-placeholder-width: 903px; --smush-placeholder-aspect-ratio: 903\/638;width:800px;height:auto\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring.png 903w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring-300x212.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring-768x543.png 768w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring-793x560.png 793w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring-453x320.png 453w\" data-sizes=\"(max-width: 903px) 100vw, 903px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" \/><noscript><img decoding=\"async\" width=\"903\" height=\"638\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring.png\" alt=\"\" class=\"wp-image-5910\" style=\"width:800px;height:auto\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring.png 903w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring-300x212.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring-768x543.png 768w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring-793x560.png 793w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring-453x320.png 453w\" sizes=\"(max-width: 903px) 100vw, 903px\" \/><\/noscript><\/figure>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-clinical-trial-monitoring-in-china\"><strong>Clinical Trial Monitoring in China<\/strong><\/h2>\n\n\n\n<p>Our Global Clinical Trial Monitoring Team are experienced in the challenges of Clinical Trial Device Monitoring within the China region.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Use of an assay in Chinese based clinical trials is monitored regularly by the Almac Global Clinical Trial Monitoring Team to ensure adherence to the clinical trial protocol.<\/li>\n\n\n\n<li>Almac\u2019s Global Clinical Trial Monitoring Team support clients with knowledge of global regulatory regulations including China.<\/li>\n\n\n\n<li>Almac employ Global Clinical Trial Monitors whose native languages are Mandarin and Cantonese and who work with our China Lab partners to keep open lines of communication &amp; promptly resolve any issues that may arise.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-china-region-diagnostic-services\"><strong>China Region Diagnostic Services<\/strong><\/h2>\n\n\n\n<p>Almac Diagnostic Services has been working with Chinese partner labs for many years, supporting biomarker programmes on behalf of our key global Biopharma clients.<\/p>\n\n\n\n<p>We have established strong trusting relationships with our partners, built the framework and put in place robust processes to enable Almac to support Chinese biomarker studies on behalf of our sponsors.<\/p>\n\n\n\n<p>Almac can support your&nbsp;<strong>Genomic Services<\/strong>,&nbsp;<strong>Clinical Biomarker &amp; CDx Development<\/strong>&nbsp;and&nbsp;<strong>Clinical Testing<\/strong>&nbsp;programmes in China.<\/p>\n\n\n\n<p>Our partnership model enables Almac to be your one point of contact for multi-arm global studies, including the China region.<\/p>\n\n\n\n<p>Find out more on our <a href=\"https:\/\/www.almacgroup.com\/diagnostics\/china-region-diagnostic-services\/\">China Region Diagnostic Services<\/a><\/p>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<div class=\"u-flex u-block@m\">\n<div class=\"u-align-center u-p-a2 u-bg-light-grey u-m-r1 u-m-b1\" style=\"max-width: 400px;\">\n<h3><\/h3>\n<h3><strong><span style=\"color: #0064a8;\">Blog:<\/span><\/strong><\/h3>\n<p>Read our latest blog entitled \u2018Clinical Trial Monitoring of IVD Devices in China. Overcoming challenges with strategies for success\u2019.<\/p>\n<p>&nbsp;<\/p>\n<p class=\"u-m-t2\"><a class=\"c-btn&quot;\" href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/clinical-trial-monitoring-of-ivd-devices-in-china-overcoming-challenges-with-strategies-for-success\/?bu=diagnostic-services\">Read Blog<\/a><\/p>\n<\/div>\n<p><a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/clinical-trial-monitoring-of-ivd-devices-in-china-overcoming-challenges-with-strategies-for-success\/?bu=diagnostic-services\"><img decoding=\"async\" class=\"alignnone size-medium wp-image-5900 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-211x300.png\" alt=\"\" width=\"211\" height=\"300\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-211x300.png 211w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-720x1024.png 720w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-394x560.png 394w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-225x320.png 225w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1.png 745w\" data-sizes=\"(max-width: 211px) 100vw, 211px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 211px; --smush-placeholder-aspect-ratio: 211\/300;\" \/><noscript><img decoding=\"async\" class=\"alignnone size-medium wp-image-5900\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-211x300.png\" alt=\"\" width=\"211\" height=\"300\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-211x300.png 211w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-720x1024.png 720w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-394x560.png 394w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1-225x320.png 225w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Almac-voice-IVD-devices-cover-1.png 745w\" sizes=\"(max-width: 211px) 100vw, 211px\" \/><\/noscript><\/a><\/p>\n<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<!-- Half image, half text -->\n<section class=\"u-bg-white t-theme-component-overwrite\" id=\"halfMediaTextBlock\">\n    <div class=\"c-half-media-text \">\n        <div class=\"o-wrapper\">\n                                                        <article class=\"o-grid u-bg-light-grey\">\n                            <div class=\"u-width-half u-width-7\/12@l u-width-full@m c-half-media__repeat-text none u-bg-light-grey\">\n                                                                <h3>Contact Us<\/h3>\n<p>For further information on how we can support Clinical Device Monitoring within your Clinical Trial, simply fill in the form below and we will be in touch to discuss your specific requirements.<\/p>\n<p>&nbsp;<\/p>\n                                                                    <a class=\"c-btn c-btn-secondary c-btn--none u-m-t2 u-m-t0@m\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/contact-us\/\">Contact us<\/a>\n                                                            <\/div>\n                            <div class=\"u-width-half u-width-5\/12@l u-width-full@m u-flex c-half-media__repeat-image\">\n                                                                    <img decoding=\"async\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2022\/12\/Dx-china-contact-image-e1670863136570.jpg\" alt=\"\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" class=\"lazyload\" style=\"--smush-placeholder-width: 1000px; --smush-placeholder-aspect-ratio: 1000\/507;\"><noscript><img decoding=\"async\" class=\"\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2022\/12\/Dx-china-contact-image-e1670863136570.jpg\" alt=\"\"><\/noscript>\n                                                            <\/div>\n                        <\/article>\n                                        <\/div>\n    <\/div>\n<\/section>\n\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Clinical Trial Monitoring Team Experienced Team Almac Diagnostic Services has a dedicated Global Clinical Trial Monitoring Team, experienced in Monitoring Clinical Device Trials globally. Our team ensure effective and efficient Clinical Trial Device Monitoring across a range of diverse diagnostic device technologies (such as qPCR, NGS, NanoString, IHC, ELISA). Independent Analysis The Global Clinical Trial [&hellip;]<\/p>\n","protected":false},"author":1870,"featured_media":0,"parent":28,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-5884","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Clinical Trial Monitoring - Diagnostic Services<\/title>\n<meta name=\"description\" content=\"Discover Almac&#039;s expert Clinical Trial Monitoring services, ensuring compliance, patient safety, and data integrity for diagnostic device trials globally.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/clinical-trial-monitoring\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Trial Monitoring\" \/>\n<meta property=\"og:description\" content=\"Discover Almac&#039;s expert Clinical Trial Monitoring services, ensuring compliance, patient safety, and data integrity for diagnostic device trials globally.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/clinical-trial-monitoring\/\" \/>\n<meta property=\"og:site_name\" content=\"Diagnostic Services\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-17T18:28:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/03\/Clinical-device-trial-monitoring.png\" \/>\n\t<meta property=\"og:image:width\" content=\"903\" \/>\n\t<meta property=\"og:image:height\" content=\"638\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/clinical-trial-monitoring\/\",\"url\":\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/clinical-trial-monitoring\/\",\"name\":\"Clinical Trial Monitoring - 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