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elementor-size-default">Global Clinical Development</h1> </div> </div> <div class="elementor-element elementor-element-1ce1fd2 e-flex e-con-boxed e-con e-child" data-id="1ce1fd2" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-0373dcb e-con-full e-flex e-con e-child" data-id="0373dcb" data-element_type="container"> <div class="elementor-element elementor-element-39b9864 elementor-widget__width-initial elementor-widget elementor-widget-text-editor" data-id="39b9864" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p class="s5"><span class="s4">We </span><span class="s4">provi</span><span class="s4">de</span><span class="s4"> global </span><span class="s4">clinic</span><span class="s4">o</span><span class="s4">-regulatory services to </span><span class="s4">pharmabiotech</span><span class="s4"> and medical device </span><span class="s4">companies for the development of new chemical entities</span><span class="s4">,</span><span class="s4"> biologicals</span><span class="s4"> and medical devices</span><span class="s4">. </span></p><p class="s5"><span class="s4">We </span><span class="s4">strategize, develop dossiers and coordinate for</span><span class="s4"> pre-IND and scientific advice meetings to firm up the clinical development plans and regulatory strategies. </span></p><p class="s5"><span class="s4">We are also working on subsequent IND projects for the Life Cycle Management of pharmaceuticals.</span></p> </div> </div> <div class="elementor-element elementor-element-7152929 elementor-widget elementor-widget-button" data-id="7152929" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact-us/"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Talk to Our Expert</span> </span> </a> </div> </div> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-b5be405 e-flex e-con-boxed e-con e-parent" data-id="b5be405" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-d13440b elementor-widget elementor-widget-heading" data-id="d13440b" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">We Support Companies</h2> </div> </div> <div class="elementor-element elementor-element-a0e448d elementor-widget__width-initial elementor-widget elementor-widget-text-editor" data-id="a0e448d" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span class="s4">Development of efficient clinical development plans acceptable to different </span><span class="s4">Competent A</span><span class="s4">uthorities</span></p><p><span class="s4">Facilitating pre-IND, End of Phase and pre-NDA submission meetings with regulators to develop and fine-tune clinical development plan.</span></p><p><span class="s4">Filing and maintaining IND in the US, clinical trial applications in the EU and India </span></p><p><span class="s4">Global solutions for CLINEXEL clients through worldwide clinical trials</span></p> </div> </div> </div> </div> <div class="elementor-element elementor-element-4384854 e-flex e-con-boxed e-con e-parent" data-id="4384854" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-ce209a1 elementor-widget elementor-widget-heading" data-id="ce209a1" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">Clinexel is a Member of the AICROS (www.aicros.com) AICROS- Association of International Clinical Research Organizations</h1> </div> </div> <div class="elementor-element elementor-element-f1a452e elementor-align-left elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="f1a452e" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-arrow-alt-circle-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z"></path></svg> </span> <span class="elementor-icon-list-text">AICROS is an official network of 8 small and mid-size CROs</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-arrow-alt-circle-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z"></path></svg> </span> <span class="elementor-icon-list-text">AICROS CRO members have a proven track record of providing high-quality clinical research services to the pharma industry.</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-arrow-alt-circle-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z"></path></svg> </span> <span class="elementor-icon-list-text">As an alliance of local and well-established CROs, we combine our strengths and know-how to accomplish the clinical development goals of our clients.</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-arrow-alt-circle-right" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z"></path></svg> </span> <span class="elementor-icon-list-text">AICROS's success is based on several years of experience of working together (since 2013) in conducting phase I to IV clinical trials, non-interventional studies and clinical investigation of medical devices all over the world.</span> </li> </ul> </div> </div> </div> </div> <div class="elementor-element elementor-element-f580dc6 e-flex e-con-boxed e-con e-parent" data-id="f580dc6" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-d3f8693 elementor-widget elementor-widget-heading" data-id="d3f8693" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">How does it Work? </h2> </div> </div> <div class="elementor-element elementor-element-8d5563c e-flex e-con-boxed e-con e-child" data-id="8d5563c" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-c70089e e-flex e-con-boxed e-con e-child" data-id="c70089e" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-969214e elementor-widget elementor-widget-heading" data-id="969214e" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">Selection of Countries </h1> </div> </div> <div class="elementor-element elementor-element-91c5e05 elementor-widget elementor-widget-text-editor" data-id="91c5e05" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span class="s4">For a global clinical trial, clients are provided options of various countries where AICROS members are present with details about regulatory requirements and clinical trial approval timelines, medical practices, experience of trial sites and local CRO in the therapeutic area and recruitment projections, with costing. </span></p> </div> </div> </div> </div> <div class="elementor-element elementor-element-878600f e-flex e-con-boxed e-con e-child" data-id="878600f" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-17a0bf3 elementor-widget elementor-widget-heading" data-id="17a0bf3" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">Centralized Project Management </h1> </div> </div> <div class="elementor-element elementor-element-c0e610a elementor-widget elementor-widget-text-editor" data-id="c0e610a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span class="s4">One of the AICROS members will take up the project management and other CROs will provide local regulatory, site selection, monitoring, and study management services and will facilitate in the logistics of import of IP and clinical trial supplies and export of samples to the central lab.</span></p><p><span class="s4">Activities like medical writing, medical and safety monitoring, data management, statistical analysis as well as management of subcontracted vendors like a central lab, will be centralized and managed by one CRO.</span></p> </div> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-1aaefdd e-flex e-con-boxed e-con e-child" data-id="1aaefdd" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-4d4a4b5 e-flex e-con-boxed e-con e-child" data-id="4d4a4b5" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-ef8d558 elementor-widget elementor-widget-heading" data-id="ef8d558" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default">One Point of Contact</h1> </div> </div> <div class="elementor-element elementor-element-570c67e elementor-widget elementor-widget-text-editor" data-id="570c67e" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p><span class="s4">C</span><span class="s4">lients will be interacting mainly with the Project Management team</span><span class="s4"> (single point of contact)</span><span class="s4">who in turn will coordinate with local CROs, who are AICROS member CROs.</span></p> </div> </div> </div> </div> <div class="elementor-element elementor-element-57b25fd e-flex e-con-boxed e-con e-child" data-id="57b25fd" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element 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