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Cell And Gene Therapy Consulting Services | TrakCel

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</li> <li class="social-list__item social-list__item--youtube"> <a href="https://www.youtube.com/channel/UCeovK0jhNtXZ8kV1Z7lZC0A" class="social-list__link" rel="nofollow noreferrer" target="_blank"> <span class="sr-only">You Tube</span> <img class="fa-svg-icon" src="https://trakcel.com/wp-content/themes/trakcel/assets/images/fa-youtube.svg" alt="Youtube" width="22" height="22" /> </a> </li> </ul> </div> <!-- mobile nav button --> <button class="navbar-toggler" type="button" data-target="#navbarNavDropdown" aria-controls="navbarNavDropdown" aria-expanded="false" aria-label="Toggle navigation"> <span class="sr-only">Menu</span> <span class="navbar-toggler-icon"></span> </button> </nav><!-- .site-navigation --> </div><!-- .wrapper-navbar end --> </div> </div> </div> </header> <!-- Open container with id="content" for accessibility skip to content link to work --> <main id="content" class="block-wrapper" role="main"> <div class="kb-row-layout-wrap kb-row-layout-id22158_9289e2-e4 alignwide wp-block-kadence-rowlayout"><div class="kt-row-column-wrap kt-has-2-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top kt-inner-column-height-full"> <div class="wp-block-kadence-column kadence-column22158_b3e310-18"><div class="kt-inside-inner-col"> <h1 class="wp-block-heading">Cell and Gene Therapy Consulting Services</h1> <p>TrakCel Consulting are proud to offer the following cell and gene therapy consulting services; COI and methodology, data protection compliance, label design and compliance, supply chain risk assessment, and SaaS within pharma.</p> <p></p> <p>View the full list of cell and gene therapy consulting services below;</p> </div></div> <div class="wp-block-kadence-column kadence-column22158_979470-18"><div class="kt-inside-inner-col"></div></div> </div></div> <div class="kb-row-layout-wrap kb-row-layout-id22158_5a0fd2-a6 alignwide wp-block-kadence-rowlayout"><div class="kt-row-column-wrap kt-has-2-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top"> <div class="wp-block-kadence-column kadence-column22158_32a639-91"><div class="kt-inside-inner-col"> <figure class="wp-block-image size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-red-coi-strategy-530x420-copy.webp" alt="" class="wp-image-22275 lazyload"/><noscript><img fetchpriority="high" decoding="async" width="531" height="420" src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-red-coi-strategy-530x420-copy.webp" alt="" class="wp-image-22275 lazyload" srcset="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-red-coi-strategy-530x420-copy.webp 531w, https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-red-coi-strategy-530x420-copy-300x237.webp 300w" sizes="(max-width: 531px) 100vw, 531px" /></noscript></figure> </div></div> <div class="wp-block-kadence-column kadence-column22158_0492c4-79"><div class="kt-inside-inner-col"> <h2 class="wp-block-heading">COI Strategy and Methodology</h2> <p>TrakCel Consulting Services have had a vast experience of COI strategies for all types of advanced therapies and classifications of starting material. Patient safety is at the heart of COI management, but methods used to guarantee COI fidelity should match the stage at which the advanced therapy is being supplied. Potentially utilising different strategies for early phase vs late phase vs commercial supply.</p> <p>Our cell and gene therapy consultants will evaluate different COI standards and apply them to different drug products, intermediates and starting materials (e.g., apheresis, bone marrow, tumour biopsy). Providing candid advice and strategies to address the regulatory frameworks of COI management and the practicalities of COI management.  </p> </div></div> </div></div> <div class="kb-row-layout-wrap kb-row-layout-id22158_ffffad-c4 alignwide wp-block-kadence-rowlayout"><div class="kt-row-column-wrap kt-has-2-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top kt-inner-column-height-full kb-theme-content-width"> <div class="wp-block-kadence-column kadence-column22158_5a6d91-d8"><div class="kt-inside-inner-col"> <h2 class="wp-block-heading">Data Protection and Compliance</h2> <p>Within cell and gene therapy consulting, we are often called upon to help to demonstrate which PHI is processed by which system for PHI management. To assist with PHI management TrakCel consulting services will audit all supply chain systems used (both electronic and paper) to identify and catalogue where and to what extent PHI is processed to produce a data processing diagram for an organisation. These diagrams will inform GDPR/HIPAA compliance strategies for companies processing and sub-processing PHI.</p> <p>Our cell and gene consultants will also provide information on how PHI/PII may be used as part of the COI strategy and how to address GDPR/HIPAA legislation when using PHI/PII for the purpose of COI management, and how to apply aspects of data management including consent, the right to be forgotten, and data processing limits.</p> </div></div> <div class="wp-block-kadence-column kadence-column22158_6aebe6-5d"><div class="kt-inside-inner-col"> <figure class="wp-block-image size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-data-protection-530x420-copy.webp" alt="" class="wp-image-22277 lazyload"/><noscript><img decoding="async" width="531" height="420" src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-data-protection-530x420-copy.webp" alt="" class="wp-image-22277 lazyload" srcset="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-data-protection-530x420-copy.webp 531w, https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-data-protection-530x420-copy-300x237.webp 300w" sizes="(max-width: 531px) 100vw, 531px" /></noscript></figure> </div></div> </div></div> <div class="kb-row-layout-wrap kb-row-layout-id22158_759ca6-6a alignwide wp-block-kadence-rowlayout"><div class="kt-row-column-wrap kt-has-2-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top"> <div class="wp-block-kadence-column kadence-column22158_d562f1-e2"><div class="kt-inside-inner-col"> <figure class="wp-block-image size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-labelling-530x420-copy.webp" alt="" class="wp-image-22279 lazyload"/><noscript><img decoding="async" width="531" height="420" src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-labelling-530x420-copy.webp" alt="" class="wp-image-22279 lazyload" srcset="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-labelling-530x420-copy.webp 531w, https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-labelling-530x420-copy-300x237.webp 300w" sizes="(max-width: 531px) 100vw, 531px" /></noscript></figure> </div></div> <div class="wp-block-kadence-column kadence-column22158_d3f81e-66"><div class="kt-inside-inner-col"> <h2 class="wp-block-heading">Label Design and Compliance</h2> <p>Personalized advanced therapies have a heavy reliance on clear and compliant labels to ensure patient safety. Through offering cell and gene therapy consulting to many therapy developers, our consultants have worked within a range of compliant formats for globally distributed therapies.</p> <p>Our consultants will aid with label design for clinical and commercial supply of ATMPs, this will include label design for both starting material and drug product to be included in CTAs and commercialisation applications.</p> <p>Our consultants have extensive experience at all phases of clinical trial and commercial deployment and as such can help with labelling in preparation for IND, BLA, CTA and MAA applications.</p> </div></div> </div></div> <div class="kb-row-layout-wrap kb-row-layout-id22158_74c445-37 alignwide wp-block-kadence-rowlayout"><div class="kt-row-column-wrap kt-has-2-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top kt-inner-column-height-full kb-theme-content-width"> <div class="wp-block-kadence-column kadence-column22158_ff40ce-ed"><div class="kt-inside-inner-col"> <h2 class="wp-block-heading">Supply Chain Risk Assessment</h2> <p>A supporting document that is often overlooked for BLA and MAA filings is a supply chain risk assessment. TrakCel Consulting Services can offer several experienced cell and gene therapy consultants to work with you to review your full supply chain from collection to drug product administration. Our team can produce a Failure Modes Effects Analysis (FMEA) for advanced therapy supply chains.</p> <p>The FMEA will inform therapy owner’s strategies for addressing risk when supplying advanced therapy products.</p> </div></div> <div class="wp-block-kadence-column kadence-column22158_00baed-08"><div class="kt-inside-inner-col"> <figure class="wp-block-image size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-530x420-copy.webp" alt="TrakCel Consulting Services" class="wp-image-22202 lazyload"/><noscript><img decoding="async" width="531" height="420" src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-530x420-copy.webp" alt="TrakCel Consulting Services" class="wp-image-22202 lazyload" srcset="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-530x420-copy.webp 531w, https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-530x420-copy-300x237.webp 300w" sizes="(max-width: 531px) 100vw, 531px" /></noscript></figure> </div></div> </div></div> <div class="kb-row-layout-wrap kb-row-layout-id22158_52258c-7a alignwide wp-block-kadence-rowlayout"><div class="kt-row-column-wrap kt-has-2-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top"> <div class="wp-block-kadence-column kadence-column22158_f7b3d7-51"><div class="kt-inside-inner-col"> <figure class="wp-block-image size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-saas-validation-530x420-copy.webp" alt="" class="wp-image-22282 lazyload"/><noscript><img decoding="async" width="531" height="420" src="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-saas-validation-530x420-copy.webp" alt="" class="wp-image-22282 lazyload" srcset="https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-saas-validation-530x420-copy.webp 531w, https://trakcel.com/wp-content/uploads/2024/01/trakcel-consulting-saas-validation-530x420-copy-300x237.webp 300w" sizes="(max-width: 531px) 100vw, 531px" /></noscript></figure> </div></div> <div class="wp-block-kadence-column kadence-column22158_8ae4c0-2c"><div class="kt-inside-inner-col"> <h2 class="wp-block-heading">SaaS within Pharma</h2> <p>Our ATMP consultants have seen use of Software as a Service (SaaS) systems within the pharmaceutical industry increase significantly over the last few years, with a move from on premises data storage to cloud storage. However, approving the use of SaaS systems presents pharmaceutical companies with a new challenge which goes beyond typical GxP principles.</p> <p>Reaching beyond our cell and gene therapy consulting services portfolio, we can offer pharmaceutical companies using SaaS systems access to experienced quality professionals with a strong background in SaaS solutions. This team can assist with SDLC auditing, SaaS system validation, and Quality assessments for vendor assessment/vendor management.</p> </div></div> </div></div> <div class="kb-row-layout-wrap kb-row-layout-id22158_2203ca-a1 alignwide kt-row-has-bg wp-block-kadence-rowlayout"><div class="kt-row-column-wrap kt-has-4-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top kt-inner-column-height-full kb-theme-content-width"> <div class="wp-block-kadence-column kadence-column22158_b8169f-10"><div class="kt-inside-inner-col"> <figure class="wp-block-kadence-image kb-image22158_633add-dd size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://consulting.netdemo.dev/wp-content/uploads/2023/12/TC-LogoIcon-WhyTrakcel-Wht-v1-3.webp" alt="" class="kb-img wp-image-284 lazyload"/><noscript><img decoding="async" src="https://consulting.netdemo.dev/wp-content/uploads/2023/12/TC-LogoIcon-WhyTrakcel-Wht-v1-3.webp" alt="" class="kb-img wp-image-284 lazyload"/></noscript></figure> <h3 class="wp-block-heading has-white-color has-text-color has-link-color wp-elements-8ce85b4d2f9e4c2a7f501e327abd3327">COI Strategy &amp; Methodology</h3> <p class="has-text-color has-link-color wp-elements-7aaefd27cf8a8d3e98180b2628483a56" style="color:#ffffff">Chain of Identity (COI) and Chain of Custody (COC) are critical to ensure safety and quality compliance through the personalized medicine supply chain. </p> </div></div> <div class="wp-block-kadence-column kadence-column22158_0740c4-2b"><div class="kt-inside-inner-col"> <figure class="wp-block-kadence-image kb-image22158_31b577-f5 size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://consulting.netdemo.dev/wp-content/uploads/2023/12/TC-LogoIcon-WhyTrakcel-Wht-v1-3.webp" alt="" class="kb-img wp-image-284 lazyload"/><noscript><img decoding="async" src="https://consulting.netdemo.dev/wp-content/uploads/2023/12/TC-LogoIcon-WhyTrakcel-Wht-v1-3.webp" alt="" class="kb-img wp-image-284 lazyload"/></noscript></figure> <h3 class="wp-block-heading has-white-color has-text-color has-link-color wp-elements-c10dfc14c2b7d6621f010d41c2192596">Data Protection Compliance</h3> <p class="has-text-color has-link-color wp-elements-b9ee0ab42c6d8f941479e83da79462a1" style="color:#ffffff">We understand how to manage COI whilst keeping Protected Health Information (PHI) secure.</p> </div></div> <div class="wp-block-kadence-column kadence-column22158_ccb7d2-de"><div class="kt-inside-inner-col"> <figure class="wp-block-kadence-image kb-image22158_9640a6-2d size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://consulting.netdemo.dev/wp-content/uploads/2023/12/TC-LogoIcon-WhyTrakcel-Wht-v1-3.webp" alt="" class="kb-img wp-image-284 lazyload"/><noscript><img decoding="async" src="https://consulting.netdemo.dev/wp-content/uploads/2023/12/TC-LogoIcon-WhyTrakcel-Wht-v1-3.webp" alt="" class="kb-img wp-image-284 lazyload"/></noscript></figure> <h3 class="wp-block-heading has-white-color has-text-color has-link-color wp-elements-d073644e1fd7960943385cda33cb0186">Label Design &amp; Compliance</h3> <p class="has-text-color has-link-color wp-elements-ca1ede9def90252fa2a4e8b19a2ae935" style="color:#ffffff">Label design and layout are key to compliance and requirements can vary regionally. We work to ensure label templates can be controlled centrally.</p> </div></div> <div class="wp-block-kadence-column kadence-column22158_b93ae3-6a"><div class="kt-inside-inner-col"> <figure class="wp-block-kadence-image kb-image22158_ac3e20-96 size-full"><img decoding="async" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" data-src="https://consulting.netdemo.dev/wp-content/uploads/2023/12/TC-LogoIcon-WhyTrakcel-Wht-v1-3.webp" alt="" class="kb-img wp-image-284 lazyload"/><noscript><img decoding="async" src="https://consulting.netdemo.dev/wp-content/uploads/2023/12/TC-LogoIcon-WhyTrakcel-Wht-v1-3.webp" alt="" class="kb-img wp-image-284 lazyload"/></noscript></figure> <h3 class="wp-block-heading has-white-color has-text-color has-link-color wp-elements-ed2f8fbd53a7d2ffb625895e6fdfb3b7">Supply Chain Risk Assessment</h3> <p class="has-text-color has-link-color wp-elements-80f4cf57acdda544e428f29bd649b868" style="color:#ffffff">Identifying and mitigating risks in the supply chain to minimize errors, waste and recalls to ensure successful filings.</p> </div></div> </div></div></main> <!-- Close container with id="content" for accessibility skip to content link to work --> <!-- footer start --> <footer class="footer"> <!-- container start --> <div class="container"> <div class="row justify-content-center justify-content-md-between"> <div class="col-md-2 mb-3"> <a href="https://trakcel.com" class="footer__logo"> <img src="https://trakcel.com/wp-content/uploads/2021/01/TC-LogoMaster-header.svg" alt="TrakCel" width="300" height="80" /> </a> </div> <div class="col-6 col-md-2 mb-3"> <h2 class="footer__heading"> Product </h2> <div id="footer-col-1" class="footer-menu"><ul id="menu-footer-nav-1" class="footer-column"><li itemscope="itemscope" itemtype="https://www.schema.org/SiteNavigationElement" id="menu-item-2916" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-2916 nav-item"><a title="OCELLOS" 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