{"id":1469,"date":"2018-12-17T05:10:00","date_gmt":"2018-12-17T10:10:00","guid":{"rendered":"https:\/\/clariowebstg.wpengine.com\/?post_type=case_study&#038;p=1469"},"modified":"2025-06-10T05:29:39","modified_gmt":"2025-06-10T09:29:39","slug":"global-pharmaceutical-company-drives-data-acceptability-over-95","status":"publish","type":"case_study","link":"https:\/\/clario.com\/resources\/case-studies\/global-pharmaceutical-company-drives-data-acceptability-over-95\/","title":{"rendered":"Global pharmaceutical company drives data acceptability over 95%"},"content":{"rendered":"<div class=\"clario-anchor-navigation sticky-top \">\n  <div class=\"container\">\n    <div class=\"row\">\n      <a href=\"#situation\" class=\"button active nav-link col-auto\">Situation<\/a><a href=\"#impact\" class=\"button nav-link col-auto\">Impact<\/a>            <button class=\"control arrow closed\" aria-label=\"Toggle\"><\/button>\n    <\/div>\n  <\/div>\n<\/div>\n\n<script type=\"text\/javascript\">\n  jQuery(window).on(\"load\", function() {\n    Clario.AnchorNavigation.run();\n  });\n<\/script>\n\n\n<div class=\"clario-section\">\n  <div class=\"container\">\n      \n<div class=\"row mb-2\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h2 class=\"wp-block-heading\" id=\"situation\">Situation<\/h2>\n\n\t<\/div>\n\n<\/div>\n\n\n<div class=\"row\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<p>A leading global pharmaceutical company initiated a clinical trial for a new asthma compound, leveraging standardized, centralized spirometry. During the study, there were large discrepancies in spirometry results produced by investigative sites from subjects\u2019 baseline inclusion measurements when compared to later measurements under treatment.<\/p>\n\n\t<\/div>\n\n<\/div>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"544\" height=\"355\" src=\"https:\/\/clario.com\/wp-content\/uploads\/2018\/12\/woman-in-meeting.jpg\" alt=\"Woman in meeting\" class=\"wp-image-3801\"\/><\/figure>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section light-grey-50\">\n  <div class=\"container\">\n      \n<div class=\"row\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h2 class=\"wp-block-heading\" id=\"impact\">Impact<\/h2>\n\n\n\n<p>Weekly custom reports with alerts identified intra- and inter-visit variability in FEV1 % and raw mL changes. Throughout the study, 37% of active sites received a C or lower grade in data quality, prompting further investigation. 24% of patients screened into the study were identified with out-of-range spirometry tests at over 50 different sites. Additionally, 3% of study subjects were deemed to demonstrate inexplicably high reversibility data. Armed with these insights, the study clinical team was able to effectively follow up with all responsible investigators.<\/p>\n\n\n\n<p>Some sites were put on recruitment hold and closely monitored until rapid improvement was made. Enhanced Business Intelligence recognized sites that used different patients to perform baseline and treatment spirometry, sites that produced questionable data that still met ATS\/ ERS standards (and were thus difficult to detect) and sites that were not in compliance with protocol requirements. The most critical sites with sub-optimal performance were retrained remotely or onsite to drive improvement in their decision-making process and overall data quality. <\/p>\n\n\n\n<p>Ultimately, acceptable data between the first study and the second study was increased by 4%. The ability to quickly recognize suspect or problematic data provided an additional level of assurance in regards to the data integrity and reliability of the primary endpoint. The sponsor achieved database lock on schedule and generated higher quality data for regulatory submission.<\/p>\n\n\n\n<p>Enhanced Business Intelligence for Respiratory Trials custom reports identifies low-performing sites and drives site intervention activities to stabilize data quality above 95%.<\/p>\n\n\t<\/div>\n\n<\/div>\n\n\n<div class=\"row mt-2\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h3 class=\"wp-block-heading\" id=\"h-clario-enabled-a-4-increase-in-data-acceptability-above-95-overall\">Clario enabled a 4% increase in data acceptability, above 95% overall<\/h3>\n\n\n\n<figure class=\"wp-block-image size-large p-2 white\"><img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"382\" src=\"https:\/\/clario.com\/wp-content\/uploads\/2018\/12\/Clario-data-acceptability-1200x382.jpg\" alt=\"Clario data acceptability\" class=\"wp-image-3802\" srcset=\"https:\/\/clario.com\/wp-content\/uploads\/2018\/12\/Clario-data-acceptability-1200x382.jpg 1200w, https:\/\/clario.com\/wp-content\/uploads\/2018\/12\/Clario-data-acceptability-600x191.jpg 600w, https:\/\/clario.com\/wp-content\/uploads\/2018\/12\/Clario-data-acceptability-768x245.jpg 768w, https:\/\/clario.com\/wp-content\/uploads\/2018\/12\/Clario-data-acceptability.jpg 1500w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/figure>\n\n\t<\/div>\n\n<\/div>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section clario-cta clario-cta-layout-standard  purple show-bg-pixel \">\n  <div class=\"container\">\n    <div class=\"row align-items-md-center\">\n        <div class=\"clario-cta-content col-md-6 offset-md-1 col-10\"><p class=\"h2\">Improve data quality and breathe easy in your clinical trials.<\/p><\/div><div class=\"cta-buttons offset-md-1 col-md-4 col-10\"><div class=\"clario-cta-action\"><a href=\"https:\/\/clario.com\/contact\/\" class=\"button cta-1 \">Talk to a specialist<\/a><\/div><\/div>    <\/div>\n  <\/div>\n<\/div>\n","protected":false},"featured_media":0,"template":"","tags":[],"solution_areas":[179],"therapeutic_area":[167],"class_list":["post-1469","case_study","type-case_study","status-publish","hentry"],"acf":[],"cp_meta_data":{"inline_featured_image":["0"],"_edit_lock":["1749547781:29"],"_edit_last":["29"],"page_title":[""],"_page_title":["field_615dbd9cfca50"],"case_study_introduction":["<h3>Clario Respiratory Solutions integrated with Enhanced Business Intelligence for Respiratory Trials generates high-quality data for successful regulatory submission<\/h3>\r\n<h4><strong>Summary<\/strong><\/h4>\r\n<ul>\r\n \t<li>Discrepancies found in spirometry results of initial trial<\/li>\r\n \t<li>New study designed integrating Clario Respiratory and Enhanced Business Intelligence solutions<\/li>\r\n \t<li>Consolidated site performance trending<\/li>\r\n \t<li>Weekly custom reports identified data variability<\/li>\r\n<\/ul>\r\n<h4><strong>Impact<\/strong><\/h4>\r\n<ul>\r\n \t<li>Select sites put on recruitment hold<\/li>\r\n \t<li>Increased acceptable data between studies by 4%<\/li>\r\n \t<li>Achieved database lock on schedule<\/li>\r\n \t<li>Generated higher-quality data for regulatory submission<\/li>\r\n<\/ul>"],"_case_study_introduction":["field_6152dce77ed78"],"case_study_image":[""],"_case_study_image":["field_6152dce77edb8"],"case_study_download":["2640"],"_case_study_download":["field_6152dd05722c5"],"external_link":[""],"_external_link":["field_615ef0c11046c"],"_yoast_wpseo_focuskeywords":["[{\"keyword\":\"asthma clinical trials\",\"score\":69}]"],"_yoast_wpseo_keywordsynonyms":["[\"\",\"\"]"],"_yoast_wpseo_estimated-reading-time-minutes":["2"],"_wp_old_date":["2021-10-21"],"asset_link":[""],"_asset_link":["field_61746513234de"],"_yoast_wpseo_content_score":["30"],"_yoast_wpseo_focuskw":["Respiratory Trials"],"_yoast_wpseo_metadesc":["Clario Respiratory Solutions integrated with Enhanced Business Intelligence for Respiratory Trials generates high-quality data for successful regulatory submission."],"_yoast_wpseo_linkdex":["51"],"_yoast_indexnow_last_ping":["1749547779"],"persistent_cta":["hide"],"_persistent_cta":["field_6375dc7c0b25c"],"show_popup":["0"],"_show_popup":["field_62b1aec56dcb5"],"_yoast_wpseo_wordproof_timestamp":[""],"_ame_cpe_post_policy":["{\"accessProtection\":{\"active\":\"replace\"}}"]},"_links":{"self":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/case_study\/1469","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/case_study"}],"about":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/types\/case_study"}],"version-history":[{"count":0,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/case_study\/1469\/revisions"}],"wp:attachment":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/media?parent=1469"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/tags?post=1469"},{"taxonomy":"solution_areas","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/solution_areas?post=1469"},{"taxonomy":"therapeutic_area","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/therapeutic_area?post=1469"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}