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Sample Kit Design & Manufacturing - Almac
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class="menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-3010"><a href="https://www.almacgroup.com/diagnostics/almac-diagnostic-services-overview/meet-the-team/" class="c-navbar__dropdown">About <span>Us</span></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-137"><a href="https://www.almacgroup.com/diagnostics/almac-diagnostic-services-overview/meet-the-team/">Meet the Team</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-139"><a href="https://www.almacgroup.com/diagnostics/almac-diagnostic-services-overview/our-history/">Our History</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-183"><a href="https://www.almacgroup.com/diagnostics/almac-diagnostic-services-overview/the-almac-group/">The Almac Group</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-136"><a href="https://www.almacgroup.com/diagnostics/almac-diagnostic-services-overview/government-support-for-research-development-programmes/">Government R&D Support</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-3015"><a href="https://www.almacgroup.com/diagnostics/careers/">Careers</a></li> </ul> </li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-200"><a href="https://www.almacgroup.com/diagnostics/contact-us/" class="c-navbar__dropdown">Contact Us<div class="c-menu__feature" data-url="contact-us" new-data-url="/diagnostics/contact-us/"> <figure> <img alt="Menu Feature Image" class="lazy-menu" data-src=""> </figure> <div class="text">Partner with us for your Biomarker Discovery & Clinical Trials</div> </div></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-2971"><a href="https://www.almacgroup.com/diagnostics/our-business-development-team/">Our BD Team</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-157"><a href="https://www.almacgroup.com/diagnostics/supporting-services/our-laboratories/">Laboratory Locations</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-173"><a href="https://www.almacgroup.com/diagnostics/newsletter-signup/">Sign up for our newsletter</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-155"><a href="https://www.almacgroup.com/diagnostics/contact-us/">Contact Us</a></li> </ul> </li> </ul> </li> </ul> </aside> </div> <div class="o-grid__item u-width-9/12 u-width-8/12@l u-width-full@s u-p-l4 u-p-l2@l u-p-l1@m u-p-b4 s-cms u-order-2@s"> <!-- Start of remove_page_title --> <!-- End of remove_page_title --> <p class="has-large-font-size">Sample Kit Design & Manufacturing</p> <p>For clinical trials, Almac Diagnostic Services offer a full Sample Kit Design & Manufacturing service alongside logistics capabilities honed over many years in the industry.</p> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading has-medium-font-size"><strong>Almac’s Range of Capabilities</strong></h3> <div class="c-diagnostics__capabilities u-hidden u-block@l"> <img decoding="async" class="alignnone size-large wp-image-54062" src="" alt="Almac Group logo" width="180"> Sample Collection Kit Manufacturing & Logistics Service <img decoding="async" class="alignnone size-full lazyload" data-src="/diagnostics/wp-content/uploads/sites/3/2020/03/dx-cards.jpg" alt="cards" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" style="--smush-placeholder-width: 640px; --smush-placeholder-aspect-ratio: 640/394;"><noscript><img decoding="async" class="alignnone size-full" src="/diagnostics/wp-content/uploads/sites/3/2020/03/dx-cards.jpg" alt="cards"></noscript> <ul> <li><a class="js-modalTrigger" href="#one" data-modal="one"> <div class="dx-icon"><img decoding="async" data-src="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/icon-forecast.png" alt="Forecast, Reporting & Planning" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" class="lazyload" style="--smush-placeholder-width: 51px; --smush-placeholder-aspect-ratio: 51/51;"><noscript><img decoding="async" src="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/icon-forecast.png" alt="Forecast, Reporting & Planning"></noscript></div> <p class="text">Forecast, Reporting & Planning</p> </a></li> <li><a class="js-modalTrigger" href="#two" data-modal="two"> <div class="dx-icon"><img decoding="async" data-src="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/icon-design.png" alt="Forecast, Reporting & Planning" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" class="lazyload" style="--smush-placeholder-width: 51px; --smush-placeholder-aspect-ratio: 51/51;"><noscript><img decoding="async" src="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/icon-design.png" alt="Forecast, Reporting & Planning"></noscript></div> <p class="text">Design & Manufacturing</p> </a></li> <li><a class="js-modalTrigger" href="#three" data-modal="three"> <div class="dx-icon"><img decoding="async" class="alignnone size-large lazyload" data-src="/wp-content/uploads/sites/3/2020/03/icon-compliance.png" alt="Regulatory Compliance" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw=="><noscript><img decoding="async" class="alignnone size-large" src="/wp-content/uploads/sites/3/2020/03/icon-compliance.png" alt="Regulatory Compliance"></noscript> </div> <p class="text">Regulatory Compliance</p> </a></li> <li><a class="js-modalTrigger" href="#four" data-modal="four"> <div class="dx-icon"><img decoding="async" class="alignnone size-large lazyload" data-src="/wp-content/uploads/sites/3/2020/03/icon-supply-chain.png" alt="Supply Chain Management" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw=="><noscript><img decoding="async" class="alignnone size-large" src="/wp-content/uploads/sites/3/2020/03/icon-supply-chain.png" alt="Supply Chain Management"></noscript> </div> <p class="text">Supply Chain Management</p> </a></li> <li><a class="js-modalTrigger" href="#five" data-modal="five"> <div class="dx-icon"><img decoding="async" class="alignnone size-large lazyload" data-src="/wp-content/uploads/sites/3/2020/03/icon-logistics.png" alt="Logistics Management" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw=="><noscript><img decoding="async" class="alignnone size-large" src="/wp-content/uploads/sites/3/2020/03/icon-logistics.png" alt="Logistics Management"></noscript> </div> <p class="text">Logistics Management</p> </a></li> <li><a class="js-modalTrigger" href="#six" data-modal="six"> <div class="dx-icon"><img decoding="async" class="alignnone size-large wp-image-54066" src="" alt="Return and Disposal"> </div> <p class="text">Return and Disposal</p> </a></li> </ul> </div> <img decoding="async" class="u-hidden@l lazyload" data-src="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/capabilities.png" usemap="#image-map" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" style="--smush-placeholder-width: 597px; --smush-placeholder-aspect-ratio: 597/566;"><noscript><img decoding="async" class="u-hidden@l" src="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/capabilities.png" usemap="#image-map"></noscript> <map name="image-map"> <area class="js-modalTrigger" title="Forecast, Reporting & Planning" alt="Forecast, Reporting & Planning" coords="597,66,371,0" shape="rect" href="#one" target="" data-modal="one"> <area class="js-modalTrigger" title="Design & Manufacturing" alt="Design & Manufacturing" coords="372,100,597,165" shape="rect" href="#two" target="" data-modal="two"> <area class="js-modalTrigger" title="Regulatory Compliance" alt="Regulatory Compliance" coords="373,198,597,267" shape="rect" href="#three" target="" data-modal="three"> <area class="js-modalTrigger" title="Supply Chain Management" alt="Supply Chain Management" coords="373,299,597,369" shape="rect" href="#four" target="" data-modal="four"> <area class="js-modalTrigger" title="Logistics Management" alt="Logistics Management" coords="373,403,597,468" shape="rect" href="#five" target="" data-modal="five"> <area class="js-modalTrigger" title="Return and Disposal" alt="Return and Disposal" coords="371,502,597,565" shape="rect" href="#six" target="" data-modal="six"> </map> <h3 class="wp-block-heading has-medium-font-size"><strong>Benefits of Combined Almac Solution</strong></h3> <p>The benefits of using Almac’s Sample Collection Kit Design, Manufacturing & Logistics service in combination with our Clinical Testing capabilities provides clients with better clinical trial outcomes in the following ways:</p> <figure class="wp-block-table"><table class="has-fixed-layout"><thead><tr><th><strong>Kit Manufacturing & Logistics</strong> </th><th> <strong>Clinical Testing</strong> </th></tr></thead><tbody><tr><td>Bespoke Packaging & Label Design service resulting in a well-designed kit minimising site errors during sample collection.</td><td><strong>Higher volume of tests ordered accurately</strong> <em>Higher percentage of adequate and legible information to proceed with assay testing.</em></td></tr><tr><td>Inclusion of bespoke labelling allows easy identification of components, patient samples and kit information. Optimised shipping routes to maintain sample integrity during transport.</td><td><strong>Increased Specimen Acceptability</strong> <em>Higher percentage of samples meet specimen acceptability criteria to proceed with assay testing.</em></td></tr><tr><td>Protocol specific shipping documentation and labelling accelerates the shipping process and reduces shipping errors. Selection of optimised shipping routes to ensure rapid return of samples. Proactive sample tracking to ensure any delays in transport are highlighted and contingencies put in place.</td><td><strong>Optimised test turnaround time</strong> <em>Higher percentage of samples meet assay test turnaround time.</em></td></tr><tr><td>Provision of a dedicated supply chain team to support clinical sites for duration of the clinical trial.</td><td><strong>Increased customer satisfaction</strong> <em>Higher percentage of clinical sites satisfied with clinical site management and assay communication</em>.</td></tr><tr><td>Clinical trial inventory management from site initiation ensuring clinical sites have the required kits for first patient in date.</td><td><strong>Greater quality control</strong> <em>Higher percentage of samples pass quality control and a valid eligibility call reported.</em></td></tr><tr><td>Ongoing stock monitoring of sample collection kits throughout the clinical trial.</td><td><strong>Enhanced trial setup & trial management service</strong> <em>Almac offer a bespoke end to end trial solution designed in line with regulatory requirements for assay testing.</em> </td></tr></tbody></table></figure> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading has-medium-font-size"><strong>Sample Collection Kit Design</strong></h3> <p>Almac Diagnostic Services can design and manufacture a range of various bespoke sample collection kits for clients’ clinical trials including the following:</p> <p><strong>Blood (and blood derivatives including plasma, serum and PBMCs)</strong></p> <ul> <li>Blood Tubes and Collection Ancillaries</li> <li>Blood Transportation Kits</li> </ul> <p><strong>FFPE Tissue</strong></p> <ul> <li>FFPE Tissue Slides & Blocks</li> </ul> <p><strong>Fresh Tissue</strong></p> <ul> <li>Fresh Tissue Samples</li> </ul> <p><strong>Liquid Specimens</strong></p> <ul> <li>Liquid Specimen Collection (Urine, Buccal, Saliva, etc.)</li> </ul> <p><strong>Temperature controlled specimens</strong></p> <ul> <li>Specimen Shipper (Temperature Controlled)</li> </ul> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <!-- Accordions --> <section class="u-bg-white u-p-y4 t-theme-component-overwrite" id="accordionBlock"> <div class="o-wrapper"> <div class="o-grid o-grid--center"> <div class="o-grid__item u-width-full u-align-center u-align-left@m"> <h2 class="u-line-height-140 u-a-center@s u-c-mid-grey"><h3 id="block-fa3cfd52-8807-4899-ab5c-f1fc9f4204a7" class="block-editor-rich-text__editable block-editor-block-list__block wp-block is-selected rich-text" style="text-align: left;" tabindex="0" role="group" contenteditable="true" aria-multiline="true" aria-label="Block: Heading" data-block="fa3cfd52-8807-4899-ab5c-f1fc9f4204a7" data-type="core/heading" data-title="Heading">Examples of Almac Diagnostic Services Sample Collection Kit Manufacture & Design:</h3> </h2> </div> <div class="o-grid__item u-width-full"> <div class="u-m-t2"> <div class="c-accordion js-accordion"> <article id="item1" class="c-accordion__item u-c-mid-grey accordion-1"> <h4 class="c-accordion__title u-bg-white u-c-mid-grey js-accordionTarget-one">Single Image Kits</h4> <div class="c-accordion__content u-bg-white"> <div class="o-grid"> <!-- if image is there then allow content to sit with it --> <!-- if not then content goes full width --> <div class="o-grid__item u-width-full"> <div class="s-cms"> <p><img fetchpriority="high" decoding="async" class="alignnone wp-image-4409" src="/diagnostics/wp-content/uploads/sites/3/2021/11/Sample-Collection-Kit-Boxes-Open-002-300x243-1.jpg" alt="" width="343" height="278" /></p> </div> </div> </div> </article> <article id="item2" class="c-accordion__item u-c-mid-grey accordion-2"> <h4 class="c-accordion__title u-bg-white u-c-mid-grey js-accordionTarget-one">Bulk Collection Kits</h4> <div class="c-accordion__content u-bg-white"> <div class="o-grid"> <!-- if image is there then allow content to sit with it --> <!-- if not then content goes full width --> <div class="o-grid__item u-width-full"> <div class="s-cms"> <p><img decoding="async" class="alignnone wp-image-724 lazyload" data-src="/diagnostics/wp-content/uploads/sites/3/2020/03/Bulk-Collection-Kits-300x206.png" alt="" width="466" height="320" data-srcset="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/Bulk-Collection-Kits-300x206.png 300w, https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/Bulk-Collection-Kits.png 645w" data-sizes="(max-width: 466px) 100vw, 466px" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" style="--smush-placeholder-width: 466px; --smush-placeholder-aspect-ratio: 466/320;" /><noscript><img decoding="async" class="alignnone wp-image-724" src="/diagnostics/wp-content/uploads/sites/3/2020/03/Bulk-Collection-Kits-300x206.png" alt="" width="466" height="320" srcset="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/Bulk-Collection-Kits-300x206.png 300w, https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/Bulk-Collection-Kits.png 645w" sizes="(max-width: 466px) 100vw, 466px" /></noscript></p> </div> </div> </div> </article> <article id="item3" class="c-accordion__item u-c-mid-grey accordion-3"> <h4 class="c-accordion__title u-bg-white u-c-mid-grey js-accordionTarget-one">Kit Design examples</h4> <div class="c-accordion__content u-bg-white"> <div class="o-grid"> <!-- if image is there then allow content to sit with it --> <!-- if not then content goes full width --> <div class="o-grid__item u-width-full"> <div class="s-cms"> <p><img decoding="async" class="alignnone wp-image-725 lazyload" data-src="/diagnostics/wp-content/uploads/sites/3/2020/03/Kit-Design-examples-300x166.png" alt="" width="500" height="277" data-srcset="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/Kit-Design-examples-300x166.png 300w, https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/Kit-Design-examples.png 640w" data-sizes="(max-width: 500px) 100vw, 500px" src="data:image/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==" style="--smush-placeholder-width: 500px; --smush-placeholder-aspect-ratio: 500/277;" /><noscript><img decoding="async" class="alignnone wp-image-725" src="/diagnostics/wp-content/uploads/sites/3/2020/03/Kit-Design-examples-300x166.png" alt="" width="500" height="277" srcset="https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/Kit-Design-examples-300x166.png 300w, https://www.almacgroup.com/diagnostics/wp-content/uploads/sites/3/2020/03/Kit-Design-examples.png 640w" sizes="(max-width: 500px) 100vw, 500px" /></noscript></p> </div> </div> </div> </article> </div> <!-- /c-tabs --> </div> </div> </div> <!-- /o-grid --> </div> <!-- /o-wrapper --> </section> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading has-medium-font-size"><strong>Logistics</strong></h3> <p>Almac Diagnostic Services partners with approved logistics specialists with extensive global reach and expert clinical trial knowledge, allowing our Logistics team to advise clients on the most appropriate courier service for their particular clinical trial needs.</p> <p>We help clients proactively solve potential logistics problems and assist to effectively navigate challenging local import and export regulations. Almac Diagnostic Services dedicated logistics and supply chain team can maximise efficiencies and ensure smooth on-site delivery of sample collection and supplies on time.</p> <p><strong>Key benefits:</strong></p> <ul> <li>Almac <strong>partnerships in place with multiple specialist global logistics companies.</strong></li> <li>Almac <strong>global import & export management experience.</strong></li> <li>Almac <strong>in-house cold chain & dangerous goods specialist.</strong></li> </ul> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> <h3 class="wp-block-heading has-medium-font-size"><strong>Brexit Planning</strong></h3> <p>Almac Diagnostic Services currently has processes in place for the import of samples from outside the EU. In the case that the UK leaves the customs union and reverts to WTO rules, Almac will use this process for the import of EU shipments.</p> <ul> <li>Additional resource has been allocated to ensure all shipments are monitored and to minimise customs clearance entering UK.</li> <li>Additional training on customs compliance.</li> <li>Almac is working with Almac-approved couriers reviewing shipping lanes for imports and updating if necessary to prevent delays.</li> <li>Almac ensure our courier partners can perform import clearance and airport recovery 24/7.</li> <li>Contingency planning and preparations have been made to ensure continuity of our service and minimise supply chain risk.</li> </ul> <p><strong>For further information on Almac Group’s Brexit strategy visit our dedicated Brexit Solution Hub <a style="color:#e63329" href="/brexit-hub/">here</a>.</strong></p> </div> </div> </div> </article> <div class="c-diagnostics__modals"> <!-- Modal one --> <div class="c-modal js-modal" title="one"> <div class="c-modal__inner"> <div class="c-modal__body"> <button class="c-modal__close js-modalClose"></button> <h4>FORECAST, REPORTING & PLANNING</h4> <ul> <li><strong>Dedicated team to meet</strong> client trial requirements <strong>and minimise costs</strong>.</li> <li><strong>Bespoke reports</strong> for effective trial management.</li> <li><strong>Supplies strategy</strong> and effective ordering <strong>to improve trial efficiency</strong>.</li> </ul> </div> </div> </div> <!-- !Modal one --> <!-- Modal two --> <div class="c-modal js-modal" title="two"> <div class="c-modal__inner"> <div class="c-modal__body"> <button class="c-modal__close js-modalClose"></button> <h4>DESIGN & MANUFACTURING</h4> <ul> <li><strong>Bespoke Packaging & Label Design</strong> service managed by a <strong>Design Specialist</strong>.</li> <li><strong>Technical consultation</strong> for component selection.</li> <li><strong>Inventory management system and temperature controlled storage solutions</strong></li> </ul> </div> </div> </div> <!-- !Modal two --> <!-- Modal three --> <div class="c-modal js-modal" title="three"> <div class="c-modal__inner"> <div class="c-modal__body"> <button class="c-modal__close js-modalClose"></button> <h4>REGULATORY COMPLIANCE</h4> <ul> <li>Adherence to <strong>global regulations for import / export</strong> and <strong>IATA</strong>.</li> <li>Sample collection kits <strong>manufactured under an ISO 13485:2016</strong> certified QMS.</li> <li><strong>ISTA and IATA package testing</strong> experience.</li> </ul> </div> </div> </div> <!-- !Modal three --> <!-- Modal four --> <div class="c-modal js-modal" title="four"> <div class="c-modal__inner"> <div class="c-modal__body"> <button class="c-modal__close js-modalClose"></button> <h4>SUPPLY CHAIN MANAGEMENT</h4> <ul> <li><strong>Dedicated supply chain team to</strong> support clinical sites for duration of the clinical trial.</li> <li><strong>Clinical site stock management</strong> at all clinical trial sites for duration of the study.</li> <li><strong>Traceability of manufactured stock</strong> at clinical sites.</li> </ul> </div> </div> </div> <!-- !Modal four --> <!-- Modal five --> <div class="c-modal js-modal" title="five"> <div class="c-modal__inner"> <div class="c-modal__body"> <button class="c-modal__close js-modalClose"></button> <h4>LOGISTICS MANAGEMENT</h4> <ul> <li><strong>Dedicated logistics team</strong> to provide solutions for your trial logistical needs.</li> <li><strong>Courier selection and setup</strong> based on individual trial requirements.</li> <li><strong>Temperature controlled solutions</strong> for transport of specimens.</li> </ul> </div> </div> </div> <!-- !Modal five --> <!-- Modal six --> <div class="c-modal js-modal" title="six"> <div class="c-modal__inner"> <div class="c-modal__body c-modal__body--narrow"> <button class="c-modal__close js-modalClose"></button> <h4>RETURN & DISPOSAL</h4> <ul> <li><strong>Recycling & destruction</strong> 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