Cell & Gene Therapy Clinical Trials | CAGT clinical research

<!DOCTYPE html>   <html lang="en">  <head> <meta charset="utf-8" /> <meta http-equiv="X-UA-Compatible" content="IE=edge"> <meta http-equiv="Content-type" content="text/html; charset=utf-8"> <meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1, user-scalable=no"> <meta http-equiv="X-UA-Compatible" content="IE=edge"> <meta name="msapplication-TileImage" content="/Content/Shotgun/img/favicon/ms-icon-144x144.png?v=4" /> <link rel="apple-touch-icon-precomposed" href="/Content/Shotgun/img/favicon/apple-icon-precomposed.png?v=4" /> <link rel="icon" href="/Content/Shotgun/img/favicon/favicon.ico?v=4" /><style> .fifty-fifty-accordion__image-box .tile-container-text .text ul li, .fifty-fifty-accordion__image-box .tile-container-text .text ol li { font-size: 14px !important; line-height: 23px !important; } </style><script id="ceros-deep-linking-plugin" data-is-embedded="yes" src="https://labs.ceros.com/sdk-plugins/deep-linking/deep-linking-plugin-v2.min.js"></script><style> .filters_wrapper { background-color: #f4f4f4 !important; } .filters .col-33 { width: 50% !important; } </style><meta name="google-site-verification" content="IxLAlrgSUUywdeoLqVfQHZzbWq0pzSRWQV-CiRbUE78" /> <script>(function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start': new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0], j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src= 'https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f); })(window,document,'script','dataLayer','GTM-P97VBCW');</script>  <script> (function(h,o,t,j,a,r){ h.hj=h.hj||function(){(h.hj.q=h.hj.q||[]).push(arguments)}; h._hjSettings={hjid:2530984,hjsv:6}; a=o.getElementsByTagName('head')[0]; r=o.createElement('script');r.async=1; r.src=t+h._hjSettings.hjid+j+h._hjSettings.hjsv; a.appendChild(r); })(window,document,'https://static.hotjar.com/c/hotjar-','.js?sv='); </script><style> .header { margin-top: 2em !important; } .header__info { position: relative !important; } .utility-buttons { position: absolute !important; top: -1em !important; right: 0px !important; } .header__button-img { margin-right: 5px !important; width: 20px !important; height: 20px !important; vertical-align: top !important; } </style><link href="https://fonts.googleapis.com/css?family=Noto+Sans:400,400i,700,700i" rel="stylesheet" type="text/css" />  <title>Cell & Gene Therapy Clinical Trials | CAGT clinical research - IQVIA Biotech</title>  <link rel="canonical" href="https://www.iqviabiotech.com/cell-and-gene-therapy-clinical-trials" /> <meta name="keywords" content="CAGT CRO, CRO partner, Cell and gene therapy clinical trials, Cell and gene therapy clinical development, CAGT clinical trials, cell therapies, gene therapies" /> <meta name="description" content="Bringing together cell and gene therapy experts, IQVIA Biotech helps you drive smarter decisions to accelerate CAGT clinical development." /> <meta name="iq:region" content="Global" /> <meta name="iq:regional_business_unit" content="Global" /> <meta name="iq:market_segment" content="Emerging Biopharma (EBP)" /> <meta name="iq:business_area" content="Research & Development Solutions" /> <meta name="iq:market_product" content="IQVIA Biotech" /> <meta name="iq:phase" content="Phase I,Phase II,Phase III" /> <meta name="iq:buyer_journey" content="General Interest,Active Exploration,Evaluation,Selection" /> <meta name="iq:persona" content="James- CEO - Emerging Biopharma" /> <meta property="og:title" content="Cell & Gene" /> <meta property="twitter:title" content="Cell & Gene" /> <meta property="og:image" content="https://www.iqviabiotech.com/-/media/iqvia/images/modules/brandworld/983_cell-and-gene-therapy.jpg" /> <meta property="twitter:image" content="https://www.iqviabiotech.com/-/media/iqvia/images/modules/brandworld/983_cell-and-gene-therapy.jpg" /> <meta property="og:description" content="<p>Cell and gene therapies (CAGT) represent a groundbreaking force in medicine and research. These cell-based and novel gene therapies have the potential to cure a disease. It is this potential to eliminate disease that makes them so revolutionary. For the researchers and developers of these innovative therapies, continuous pursuit to improve the quality of human lives remains at the core of every clinical development decision made toward advancing CAGT therapeutic options. </p> <p>Developing successful cell and gene therapy clinical trials is a complex process due to many operational challenges and regulatory scrutiny. As biotech companies embark on clinical trial planning and execution, it is critical to find a CRO delivery partner to help anticipate and navigate these operational complexities that arise when designing and running clinical trials for cell and gene therapies. </p>" /> <meta property="twitter:description" content="<p>Cell and gene therapies (CAGT) represent a groundbreaking force in medicine and research. These cell-based and novel gene therapies have the potential to cure a disease. It is this potential to eliminate disease that makes them so revolutionary. For the researchers and developers of these innovative therapies, continuous pursuit to improve the quality of human lives remains at the core of every clinical development decision made toward advancing CAGT therapeutic options. </p> <p>Developing successful cell and gene therapy clinical trials is a complex process due to many operational challenges and regulatory scrutiny. 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class="top-level-hero__inner no-padding-top no-padding-bottom"> <div class="top-level-hero__content"> <h2 class="top-level-hero__heading def-heading"> Cell and gene therapies have groundbreaking potential </h2> <div class="top-level-hero__text def-text">  <br /> <p>Pioneering methods that cut through the complex to advance your clinical trial</p> </div> <div class="top-level-hero__button-box"> <a class="top-level-hero__button def-btn" href="#contact">Let's Talk</a> </div> </div> </div> <div class="top-level-hero__image-box"> <img src="/-/media/biotech/images/hero/cagt_page.png?h=970&iar=0&w=1094&hash=3EDFA530F256064F079A7C03FE580F8F" class="top-level-hero__image" alt="" DisableWebEdit="False" /> </div> <div class="top-level-hero__image-box-mobile"> <img src="/-/media/biotech/images/hero/cagt_page.png?h=970&iar=0&w=1094&hash=3EDFA530F256064F079A7C03FE580F8F" class="top-level-hero__image" alt="" DisableWebEdit="False" /> </div> </div> </div> </section> <div class="rich-text-without-bg"> <div class="rich-text__outer"> <div class="rich-text__wrapper"> <div class="rich-text__inner no-padding-top"> <div class="rich-text__article text-page-body"> <div class="page-body"> <p>Cell and gene therapies (CAGT) represent a groundbreaking force in medicine and research. These cell-based and novel gene therapies have the potential to cure a disease. It is this potential to eliminate disease that makes them so revolutionary. For the researchers and developers of these innovative therapies, continuous pursuit to improve the quality of human lives remains at the core of every clinical development decision made toward advancing CAGT therapeutic options. </p> <p>Developing successful cell and gene therapy clinical trials is a complex process due to many operational challenges and regulatory scrutiny. As biotech companies embark on clinical trial planning and execution, it is critical to find a CRO delivery partner to help anticipate and navigate these operational complexities that arise when designing and running clinical trials for cell and gene therapies. </p> </div> </div> </div> </div> </div> </div> <div class="quotes-with-image quotes_charcoal"> <div class="quotes__outer container"> <div class="quotes__wrapper"> <div class="quotes-row"> <div class="img" style="background-image:url('/-/media/biotech/images/clinical-development/oncology/quotefinotpattern.png?h=325&w=412&hash=8876291AE4633C4A0132A9B6D1CFAA3D')"> <svg xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" width="66" height="62" viewBox="0 0 66 62"> <defs> <path id="540ha" d="M198 155h29v-25.994h-17.768l-.11-1.581c-.245-3.537.377-7.002 1.85-10.296 2.72-5.944 7.915-10.255 15.459-12.836V96c-8.95 2.072-15.901 6.007-20.681 11.713-5.143 6.14-7.75 14.687-7.75 25.406z" /> <path id="540hb" d="M163 155h29v-25.994h-17.768l-.11-1.582c-.245-3.538.378-7.002 1.85-10.295 2.72-5.944 7.915-10.255 15.459-12.836V96c-8.95 2.072-15.901 6.007-20.681 11.713-5.143 6.14-7.75 14.688-7.75 25.406z" /> </defs> <g> <g transform="translate(-162 -94)"><use fill="#00BFB3" fill-opacity="0" stroke="#00BFB3" stroke-miterlimit="50" stroke-width="2" xlink:href="#540ha" /></g> <g transform="translate(-162 -94)"><use fill="#00BFB3" fill-opacity="0" stroke="#00BFB3" stroke-miterlimit="50" stroke-width="2" xlink:href="#540hb" /></g> </g> </svg> </div> <div class="flex-column"> <div class="quotes_desc"> <p> </p> <p> </p> <p>Our experienced cell and gene team navigates the operational and logistical complexity inherent in CAGT clinical trials with ease, thereby advancing these assets forward along their development pathway for increased patient access.</p> </div> <div class="quotes_author"> Erin Finot, Vice President, Immuno-Oncology & CAGT </div> </div> </div> </div> </div> </div> <div class="image-align-box image-align-box--left"> <div class="image-align-box__outer"> <div class="image-align-box__wrapper"> <div class="image-align-box__inner"> <div class="image-align-box__image"> <div class="image-align-box__image-box"> <img src="/-/media/biotech/images/cagt/cagt_5050images890x640_1.png?h=431&iar=0&mw=600&w=600&hash=2733FD4EA59AE8DD11E666CB72784FE6" alt="" DisableWebEdit="False" /> </div> <div class="image-align-box__image-box-mobile"> <img src="/-/media/biotech/images/cagt/cagt_5050images890x640_1.png?h=431&iar=0&mw=600&w=600&hash=2733FD4EA59AE8DD11E666CB72784FE6" alt="" DisableWebEdit="False" /> </div> </div> <div class="image-align-box__content"> <h3 class="image-align-box__heading"> CAGT Study Management Team </h3> <div class="image-align-box__text"> <p>Answering the call for innovation to address specific challenges of cell and gene therapy drug development, we have formed a multidisciplinary Cell and Gene Therapy Study Management team. This comprehensive unit is designed for CAGT-focused biotech partners, integrating the IQVIA Biotech clinical program strategy and delivery with the IQVIA Cell and Gene Therapy Center of Excellence. Together, these groups form your CAGT Study Management team, dedicated to an end-to-end, seamless experience for biotech customers.</p> </div> </div> </div> </div> </div> </div> <div class="image-align-box image-align-box--right"> <div class="image-align-box__outer"> <div class="image-align-box__wrapper"> <div class="image-align-box__inner no-padding-top no-padding-bottom"> <div class="image-align-box__image"> <div class="image-align-box__image-box"> <img src="/-/media/biotech/images/cagt/cagt_5050images890x640_2.png?h=431&iar=0&mw=600&w=600&hash=81E145DAB0D2307AC3FC4087198EBACD" alt="" DisableWebEdit="False" /> </div> <div class="image-align-box__image-box-mobile"> <img src="/-/media/biotech/images/cagt/cagt_5050images890x640_2.png?h=431&iar=0&mw=600&w=600&hash=81E145DAB0D2307AC3FC4087198EBACD" alt="" DisableWebEdit="False" /> </div> </div> <div class="image-align-box__content"> <h3 class="image-align-box__heading"> Aligned CAGT strategy and delivery </h3> <div class="image-align-box__text"> <p>We believe that having our CAGT operational delivery as a streamlined process is at the heart of your program’s success. Because of this, we design your delivery strategy with the following core principles:</p> <ul> <li>Seamless CAGT solutions applied throughout the study process</li> <li>Dedicated CAGT-expert cross-functional delivery teams</li> <li>Medical expertise across all therapeutic areas</li> <li>Clinical trial design, delivery and logistics support</li> <li>Optimized communication to efficiently achieve trial milestones</li> <li>Integrate lessons learned and experiences into innovation and value for patients</li> </ul> </div> </div> </div> </div> </div> </div> <div class="fifty-fifty-accordion fifty-fifty-accordion--left"> <div class="fifty-fifty-accordion__outer"> <div class="fifty-fifty-accordion__wrapper"> <div class="fifty-fifty-accordion__inner"> <div class="fifty-fifty-accordion__image"> <div class="fifty-fifty-accordion__image-box padding"> <div class="tile-container"> <div class="tile accent_color__teal clickable-tile"> <div class="tile-heading"> Site Selection </div> <i class="fas fa-chevron-down"></i> </div> </div> <div class="tile-container-text"> <div class="text"> <p> Cell and gene therapy trials require integration and coordination across numerous disciplines, such as a leukapheresis center, cell therapy laboratory, investigational pharmacy, in-patient treatment facility, and outpatient clinics. Our team works with sites to confirm they have the requisite equipment and processes, appropriate handling knowledge, and trained staff and expertise to support cell and gene therapy studies and patients. Additionally, investigator relationships, networks, and thought leader support are paramount to concluding a comprehensive site identification strategy and running a high-quality study.</p> </div> </div> <div class="tile-container"> <div class="tile accent_color__teal clickable-tile"> <div class="tile-heading"> Regulatory </div> <i class="fas fa-chevron-down"></i> </div> </div> <div class="tile-container-text"> <div class="text"> <p> Global regulatory planning and an understanding of regional landscapes are critical to the success of CAGT development. These trials are often evaluated by specialized committees or local standards and the reviews differ from country to country. The regulatory landscape continues to evolve, for example as recent as the FDA's Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products in January 2024, and it is important for biotech companies to understand the current state and anticipate the future state, both of which may impact their CAGT development goals. Our regulatory experts help customers navigate regulatory considerations with strategic and operational guidance.</p> </div> </div> <div class="tile-container"> <div class="tile accent_color__teal clickable-tile"> <div class="tile-heading"> Logistics </div> <i class="fas fa-chevron-down"></i> </div> </div> <div class="tile-container-text"> <div class="text"> <p> CAGT clinical trials have tremendous logistical complexities, from the manufacturing supply chain of precious cell materials to the frequency of biospecimen collection during the clinical trial. A dedicated team member will oversee all communication, planning and logistics to minimize risk at sample handovers and ensure compliance and reconciliation of samples. Our innovative technology solutions can help ensure superior compliance and tracking, as well as risk mitigation of the logistics chain.</p> </div> </div> <div class="tile-container"> <div class="tile accent_color__teal clickable-tile"> <div class="tile-heading"> Experienced Teams </div> <i class="fas fa-chevron-down"></i> </div> </div> <div class="tile-container-text"> <div class="text"> <ul> <li>Supported 200 full-service CAGT clinical trials for biotech sponsors in the past 5 years </li> <li>More than 70% of project managers have 3+ years of CAGT experience </li> <li>100% dedicated to biotech customers</li> </ul> </div> </div> </div> </div> <div class="fifty-fifty-accordion__content"> <h3 class="fifty-fifty-accordion__heading teal__text"> Navigating operational complexities </h3> <div class="fifty-fifty-accordion__text"> <p> The CAGT Study Management team can help sponsors navigate operational challenges specific to cell and gene therapy trials including site selection and start-up, regulatory requirements, and intense logistical demands of product distribution and biospecimen collection. We provide data-driven guidance to enhance the probability of operational success. </p> </div> </div> </div> </div> </div> </div> <div class="point-of-view solid-color"> <div class="point-of-view__inner"> <div class="point-of-view__wrapper"> <h2 class="title">Cell and Gene Therapy Insights</h2> <div class="insights_carousel__container"> <div class="carousel_container e54af5b4f74f4e64b18ad87d3d99eb37" data-slider="e54af5b4f74f4e64b18ad87d3d99eb37"> <div class="swiper-container insights_carousel__container__swiper"> <div class="swiper-wrapper" > <div class="swiper-slide border-bottom card-link" data-target="_blank" data-target-url="https://www.iqviabiotech.com/library/white-papers/designing-and-delivering-cell-and-gene-therapy-clinical-trials"> <div class="swiper-slide_header" style="background-image: url('/-/media/biotech/images/brandworld/3174_custom-photo_grid-of-dots-and-rays-from-a-deep-space-sky.png?h=585&w=1024&hash=E0830B93EA48BB36009FCA55DFE04B00')"></div> <div 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