ICON plc | Quality

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appropriate obesity-specific trial designs, long-term follow-up studies and diverse patient recruitment.</p> </a> </div> <div class="col-xl-3"> <a href="/insights/therapeutics" class="dropdown-item dropdown-item--with-image"> <div class="image image--zoom-on-hover"> <div><div><img src="https://icon.widen.net/content/78559377-8cc3-4bc6-b6f2-cc20a04e1504/web/cells-menu-hero.jpg?crop=yes&w=260&h=136&itok=p-hsvMPd" width="260" height="136" alt="cells-menu-hero.jpg" loading="eager" title="cells-menu-hero.jpg" /> </div> </div> </div> <span class="h4">Therapeutics insights</span> <p class="section-overview--desktop">ICON's therapeutic experts contribute regularly to industry publications and the creation of thought leadership content. Read more. </p> </a> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a href="/insights" aria-expanded="false" class="nav-link dropdown-toggle" data-toggle="dropdown" role="button"> Insights <span></span> </a> <div class="menu_link_content menu-link-contentmain view-mode-main-navigation dropdown-menu"> <button class="navbar-btn navbar-btn--back" type="button"> <span class="navbar-btn__icon"></span> </button> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-xl-3"> <div class="paragraph paragraph--type--mega-menu-text paragraph--view-mode--default"> <div class="mega-menu-title"><a href="/insights" target="_self">Insights</a></div> </div> <a class="dropdown-item" href="/insights/digital-disruption">Digital Disruption</a> <a class="dropdown-item" href="/insights/patient-centricity">Patient Centricity</a> <a class="dropdown-item" href="/insights/regulatory-intelligence">Regulatory Intelligence</a> <a class="dropdown-item" 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class="section-overview--desktop">Maximising efficiency and flexibility with custom outsourcing</p> </a> </div> <div class="col-xl-3"> <a href="/insights/therapeutics-insights/oncology/de-risking-clinical-development-precision-medicines" class="dropdown-item dropdown-item--with-image"> <div class="image image--zoom-on-hover"> <div><div><img src="https://icon.widen.net/content/a2f99da8-e333-4f57-8700-d1d3f72f301e/web/MDD_OncologyWhitepaper.jpg?crop=yes&w=260&h=136&itok=V8aVKfKL" width="260" height="136" alt="Oncology whitepaper web assets" loading="eager" title="Oncology whitepaper web assets" /> </div> </div> </div> <span class="h4">De-risking clinical development of precision medicines in oncology</span> <p class="section-overview--desktop">An evolving understanding of cancer biology has resulted in the rise of precision-informed treatment approaches.</p> </a> </div> <div class="col-xl-3"> <a 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The quality of our work is vital to our mission of bringing better medications and treatments to patients around the world. We are committed to maintaining, supporting, checking and improving our quality systems to exceed the quality standards demanded by our customers, patients and regulatory authorities. </p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="f2c449d3-c22a-41d9-be16-78b0739e6247" class="icon-group icon-group--horizontal"> <div class="container-fluid container-fluid--xl"> <h2 class="icon-group__title">In the last five years* we have successfully completed:</h2> <ul class="icon-group__items icon-group__items__columns-2"> <li class="icon-group__item--green"> <div lang="en" class="icon-group__wrapper" > <i class="icon-client"></i> <p class="mb-2 icons-large-text">4,060</p> <small>Sponsor audits</small> </div> </li> <li class="icon-group__item--green-dark"> <div lang="en" class="icon-group__wrapper" > <i class="icon-notes"></i> <p class="mb-2 icons-large-text">1,151</p> <small>Supplier audits</small> </div> </li> </ul> </div> </div> <div id="b45df5ad-7fbf-4725-8243-e24d8cc8b49d" class="icon-group icon-group--horizontal"> <div class="container-fluid container-fluid--xl"> <ul class="icon-group__items icon-group__items__columns-2"> <li class="icon-group__item--blue"> <div lang="en" class="icon-group__wrapper" > <i class="icon-content-development"></i> <p class="mb-2 icons-large-text">12,181</p> <small>Internal audits</small> </div> </li> <li class="icon-group__item--blue-light"> <div lang="en" class="icon-group__wrapper" > <i class="icon-focal-point"></i> <p class="mb-2 icons-large-text">641</p> <small>Regulatory inspections</small> </div> </li> </ul> </div> </div> <div id="e473de15-1bec-4677-a5c3-5a5264b8182d"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> </h3> <div><h6>*2020 to Aug 2024</h6></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="d6cb2d53-fe26-42df-9843-2265d8d98625"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> </h3> <div> <p>The quality of our work is vital to our mission of bringing better medications to patients around the world. We are committed to maintaining, supporting, checking and improving our quality systems to exceed the quality standards demanded by our clients, patients and regulatory authorities.</p> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="47cb92d6-2287-4c3c-a789-3c0933ca9f8b"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 1x, https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 1x, https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 1x, https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 1x, https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 1x, https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 1x, https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png?crop=yes&w=1110&h=678&a=0,0&itok=yXVSnWC3 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/4tfrqnknnq/web/2024%20CROLA-quality.png" width="1110" height="678" alt="2024 CROLA-quality" title="2024 CROLA-quality" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2>2024 CRO Leadership Awards: Quality</h2> <h3></h3> <div><p>ICON has been recognised for 'having exceeded customer expectations' for 'data quality' in the 2024 CRO Leadership Awards. ICON was the most awarded CRO across over 20 performance metrics.</p><p>These awards are the result of an annual CRO Quality benchmarking research conducted via an online survey, by ISR. 46 service providers were evaluated on 20+ different performance metrics.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="20ab509b-faa0-4885-b332-ccd4167c3326"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> Quality Management System </h3> <div> <p>ICON’s Quality Management System (QMS) comprises our mechanisms for ensuring that all our services are performed to the highest ethical standards, conform to all relevant regulatory requirements and satisfy contractual obligations. The QMS is based on continual improvement, with ongoing measurement of process performance to determine the effectiveness of the QMS.</p> <p>The sequence and interaction of each process are defined within ICON process documentation, including the methods for control and the metrics for measuring overall effectiveness. It is proactive, data-driven and capable of detecting signals and trends, profiling and addressing risks to keep projects Inspection ready at all times. ICON's comprehensive quality system is constructed from the following key elements:</p> <ul> <li>Process</li> <li>Compliance</li> <li>Quality Assurance</li> <li>Risk</li> <li>Analytics & Reporting</li> </ul> <p>The key elements are further defined in the graphic below:</p> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="f10d69f6-c251-46e0-978e-01c08250e460"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-picture--picture-only text-left "> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=dEYQ6sRC 1x, https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=dEYQ6sRC 2x" media="(min-width: 1400px)" width="1170" height="658"/> <source srcset="https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=dEYQ6sRC 1x, https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=dEYQ6sRC 2x" media="(min-width: 1200px)" width="1170" height="658"/> <source srcset="https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=dEYQ6sRC 1x, https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=dEYQ6sRC 2x" media="(min-width: 992px) and (max-width: 1199px)" width="1170" height="658"/> <source srcset="https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=VpZoYVYS 1x, https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=VpZoYVYS 2x" media="(min-width: 768px) and (max-width: 991px)" width="768" height="432"/> <source srcset="https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=VpZoYVYS 1x, https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=658&a=0,0&itok=VpZoYVYS 2x" media="(min-width: 576px) and (max-width: 767px)" width="768" height="432"/> <source srcset="https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=657&a=0,1&itok=k49PfvJg 1x, https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg?crop=yes&w=1170&h=657&a=0,1&itok=k49PfvJg 2x" media="(max-width: 575px)" width="340" height="191"/> <img src="https://icon.widen.net/content/cz6v1evu1m/web/governance-qms-graphic.jpg" width="1170" height="658" alt="governance-qms-graphic" title="governance-qms-graphic" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> </div> </div> </div> </div> <div id="0f4900f7-0406-44ef-8555-512511cd9b87"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> Standard Operating Procedures </h3> <div> <p>ICON has a comprehensive library of global Standard Operating Procedures (SOPs) which:</p> <ul> <li>Ensure that all client requirements are met</li> <li>Enable employees to conform to and document GxP, and Regulatory requirements</li> <li>Ensure that all company activities are controlled and documented</li> <li>Provide guidance for staff development and training</li> </ul> <p>All ICON's activities are conducted in compliance with these global procedures and, when necessary, office-specific or region-specific procedures may be prepared. In addition, we have the flexibility to operate with our client's SOPs when requested.</p> <p>SOPs are reviewed regularly for continuing suitability and are updated as required. All our SOPs are available for viewing in any of our offices.</p> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="8c9d6f42-71aa-4172-a619-a241e77212f6"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> Quality Assurance Services </h3> <div><p>In addition to providing in-house Quality Assurance auditing for clinical trials, the Quality Assurance department provides stand-alone services to support companies to develop, implement and maintain quality management systems to assure the highest standard of conformance to GCP, GVP (Pharmacovigilance), GMP and GLP regulations.</p><p>ICON has the resources to meet all your auditing requirements for both <a href="/therapeutics/medical-device/" target="_self">Medical Device</a> and Drug including <a href="/solutions/early-phase/" target="_self">Early Clinical</a>, and Phase II - IV clinical trials and post-marketing activities. With QA auditing personnel located across Europe, the Americas and Asia-Pacific, the ICON QA team is flexible enough audit global programs as well as provide individual and personalised service for locally managed projects.</p><p>The following QA services are provided on a stand-alone or project-specific basis. Audits/ assessments cover:</p><ul><li>Phase I - IV GCP audits</li><li>Medical Device audits</li><li>Laboratories (GCP, GLP, GCLP)</li><li>SDLC and Computer validation</li><li>Technical and operational vendor/supplier audits, assessments and qualifications</li><li>Investigational site audits and inspection preparatory assessments</li><li>Safety Surveillance/Pharmacovigilance</li></ul></div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </second> </div> <div class="col-md-3 order-1"> <div id="cd9c6cb3-4fa2-46da-bde2-f3ac7a3d4651"> <div class="container-fluid container-fluid--xl sidebar-menu-wrapper"> <div class="sidebar"> <div class="sidebar sidebar--sticky sidebar--collapsible"> <a class="sidebar--collapsible__toggle collapsed" role="button" data-toggle="collapse" href="#sidebar-content" aria-expanded="false" aria-controls="sidebar-content"> <span>In this section</span> </a> <div class="sidebar--collapsible__content collapse" id="sidebar-content"> <div 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