Real World Data Solutions | Integrated Evidence

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<a role="menuitem" href="#" data-sidebar="sidebar-products-ai" > <span>Medidata AI</span> </a> <div class="sub-menu row"> <div class="menu-col-1"> <ul role="menu" aria-label="Medidata AI" class=level-2> <li class=" menu-item menu-item-type-custom menu-item-object-custom menu-item-69451" role="presentation"> <a role="menuitem" href="/en/clinical-trial-products/medidata-ai/" data-sidebar="" > <span>Medidata AI Overview</span> </a> <p class="text-paragraph sm">The data, tools and insight you need to reimagine clinical trials & propel innovation.</p> </li> <li class=" menu-item menu-item-type-post_type menu-item-object-page_v2 current-menu-item menu-item-108215" role="presentation"> <a role="menuitem" href="https://www.medidata.com/en/clinical-trial-products/medidata-ai/real-world-data/" data-sidebar="" > <span>Integrated Evidence</span> </a> <p class="text-paragraph sm">Connecting historical insights & real-world data to increase trial success probability.</p> </li> <li class=" menu-item 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</div> </header> <div class="content-wrap"> <section class="com v3-crumbs v3"> <div class="v3-wrap row"> <div class="col-xs-12"> <div class="crumbs"> <a class="crumb" href="https://www.medidata.com/en/clinical-trial-products/medidata-ai/" target="_blank"> Medidata AI </a> <a class="crumb" href="#" > Integrated Evidence </a> </div> </div> </div> </section> <section class="com v3-media-mod v3" > <div class="v3-wrap row" > <div class="a2 md-media col-xs-12 col-sm-10 col-md-6"> <div class="v3-media-wrap"> <div class="v3-visual-image" > <picture class="image-media image-media-aspect w-full"> <img fetchpriority="high" decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/08/v2_-MITTR-MedidataCover.738png-1264x710-c-top.webp" width="1264" height="710" class="" alt="" loading="auto" /> </picture> </div> </div> </div> <div class="a md-text col-xs-12 col-sm-10 col-md-6 first-xs"> <div class="text-white mt-3 lg:mt-0"> <h1 class="h-lg hh1"><span class="text-brand-blue">Integrated Evidence</span></h1> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70" style="font-weight: 400;">Medidata AI Integrated Evidence connects historical data from more than 33,000 cross-sponsor clinical trials and 10 million patient volunteers with real world data to deliver powerful insights and the necessary evidence clinical development leaders need to increase the probability of trial success.</span></p> <p><span class="text-nutral-70" style="font-weight: 400;">Artificial intelligence and data can help fuel new ways of working on clinical trials and beyond.</span></p> </div> <div class="pt-2 v3-button-wrap a" > </div> </div> </div> </section> <section class="com v3-tabs-media v3 ui-ta"> <div class="v3-wrap py-120px row" > <div class="a v3-header col-xs-12 row w-full"> <div class="col-xs-12 col-sm-8"> <div class="mb-4 "> <h2 class="h-lg hh2"><span class="text-brand-blue">Clinical Trial Data Informing Today’s Trials</span></h2> </div> <div class="bt mb-1 "> </div> </div> </div> <div class="col-xs-12 !hidden md:!flex mt-[30px]"> <div class="v3-h-tabs"> <a href="#develop-powerful-insights" class="ui-tab noscroll is-active"> Develop Powerful Insights </a> <a href="#increase-probability-of-trial-success" class="ui-tab noscroll "> Increase probability of trial success </a> <a href="#make-evidence-based-decisions" class="ui-tab noscroll "> Make evidence-based decisions </a> </div> </div> <div class="ui-panels"> <div id="develop-powerful-insights" class="ui-panel is-active"> <button class="md:!hidden ui-ac-bar ui-title dark col-xs-12" data-hash="#develop-powerful-insights"> Develop Powerful Insights <span>Expand</span> </button> <div class="ui-ac-body"> <section class="com v3-media-mod v3" > <div class="row" > <div class="a2 md-media col-xs-12 col-sm-10 col-md-6"> <div class="v3-media-wrap"> <div class="v3-visual-image" > <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2022/11/2022_Nov_GIF_SCA-Integrated-Evidence-1.gif" width="1264" height="710" class="" alt="" loading="auto" /> </picture> </div> </div> </div> <div class="a md-text col-xs-12 col-sm-10 col-md-6 "> <div class="text-white mt-3 lg:mt-0"> <h3 class="hh3"><span class="text-brand-blue">Develop Powerful Insights</span></h3> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70">Medidata AI offers the world’s largest source of cross-sponsor, historical clinical trial data – made up of more than 33,000 trials, 10 million patients, and pre-integrated real world data (RWD) to offer solutions that give you the best chance of trial and regulatory success. Especially in a rapidly evolving clinical development landscape where RWD alone can often fall short in providing the insights and evidence necessary for your clinical development programs.</span></p> </div> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://www.medidata.com/wp-content/uploads/2024/08/Synthetic-Control-Arm-SCA-Fact-Sheet-May-24.pdf" target="_blank"> Learn more about Synthetic Control Arm </a> </div> </div> </div> </section> </div> </div> <div id="increase-probability-of-trial-success" class="ui-panel "> <button class="md:!hidden ui-ac-bar ui-title dark col-xs-12" data-hash="#increase-probability-of-trial-success"> Increase probability of trial success <span>Expand</span> </button> <div class="ui-ac-body"> <section class="com v3-media-mod v3" > <div class="row" > <div class="a2 md-media col-xs-12 col-sm-10 col-md-6"> <div class="v3-media-wrap"> <div class="v3-visual-image" > <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/08/Analytics-Tablet-1264x710-c-top.webp" width="1264" height="710" class="" alt="" loading="auto" /> </picture> </div> </div> </div> <div class="a md-text col-xs-12 col-sm-10 col-md-6 "> <div class="text-white mt-3 lg:mt-0"> <h3 class="hh3"><span class="text-brand-blue">Increase probability of trial success</span></h3> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70" style="font-weight: 400;">Medidata AI’s data, insights, and expertise give clinical development leaders and their trials the best chance at success – from a better designed trial, to a more scientifically-rigorous Synthetic Control Arm® (SCA®), to stronger positioning of a drug for commercialization.</span></p> </div> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://www.medidata.com/wp-content/uploads/2024/08/Trial-Design-Case-Study-eBook-May-24.pdf" target="_blank"> Learn more about Synthetic Control Arm </a> </div> </div> </div> </section> </div> </div> <div id="make-evidence-based-decisions" class="ui-panel "> <button class="md:!hidden ui-ac-bar ui-title dark col-xs-12" data-hash="#make-evidence-based-decisions"> Make evidence-based decisions <span>Expand</span> </button> <div class="ui-ac-body"> <section class="com v3-media-mod v3" > <div class="row" > <div class="a2 md-media col-xs-12 col-sm-10 col-md-6"> <div class="v3-media-wrap"> <div class="v3-visual-image" > <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2022/11/Integrated-Evidence-thumbnail-1264x710-c-top.webp" width="1264" height="710" class="" alt="" loading="auto" /> </picture> </div> </div> </div> <div class="a md-text col-xs-12 col-sm-10 col-md-6 "> <div class="text-white mt-3 lg:mt-0"> <h3 class="hh3"><span class="text-brand-blue">Make evidence-based decisions</span></h3> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70" style="font-weight: 400;">Rising costs, evolving standards of care, and decreased patient recruitment and retention all mean that making the right decisions earlier is more important than ever. Medidata AI provides powerful modeling along with deep regulatory, clinical, and commercial expertise to help you make evidence-based decisions with more confidence.</span></p> </div> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://www.medidata.com/wp-content/uploads/2024/08/Medidata-AI-Synthetic-Control-Arm-eBook-May-24.pdf" target="_blank"> Download eBook </a> </div> </div> </div> </section> </div> </div> </div> </div> </section> <section class="com v3-accordion v3 ui-ac" > <div class="v3-wrap row" > <div class="a col-xs-12 p-0 col-md-5"> <div class="a v3-header col-xs-12 row w-full"> <div class="col-xs-12 col-sm-9"> <div class="mb-4 "> <h2 class="h-lg hh2"><span class="text-brand-blue">Key Features</span></h2> </div> <div class="bt mb-1 "> </div> </div> </div> <div class="v3-col mt-[40px]"> <div class="pt-2 v3-button-wrap " > </div> </div> </div> <div class="a2 ui-panels col-xs-12 col-md-7 p-0"> <div class="ui-panel p-6 mb-5 is-active a" id="1"> <button class="ui-ac-bar ui-title dark p-0"> <b class="hh5">Regulatory-grade Clinical Trial Data</b> <span>Expand</span> </button> <div class="ui-ac-body"> <div class="mt-5"> <div class="v3-media-wrap"> <div class="v3-visual-image" style="aspect-ratio:1264/710"> <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2022/09/data-quality-1264x710-c-top.webp" width="1264" height="710" class="" alt="Regulatory-grade Clinical Trial Data" loading="auto" /> </picture> </div> </div> </div> <div class="mt-5"> <h3 class="hh3"><span class="text-brand-blue">Regulatory-grade Clinical Trial Data</span></h3> </div> <p><span class="text-nutral-70" style="font-weight: 400;">Medidata AI Synthetic Control Arm and Trial Design provides truly “regulatory grade” data, containing traditional clinical trials style endpoints and complete covariate information, as they were designed in the clinical protocol, and subsequently captured, monitored and validated in the Medidata Rave electronic data capture (EDC) platform. The repository enables data-driven decision making by providing patient-level data in the common domains and over 100 harmonized variables.</span></p> <div class="mt-auto"> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://assetlibrary.medidata.com/m/721d2eca4217a68a/original/Synthetic-Control-Arm-Whitepaper-Nov-21.pdf" target="_blank"> Read our SCA White Paper </a> </div> </div> </div> </div> <div class="ui-panel p-6 mb-5 a" id="2"> <button class="ui-ac-bar ui-title dark p-0"> <b class="hh5">Best-in-class Expertise</b> <span>Expand</span> </button> <div class="ui-ac-body"> <div class="mt-5"> <div class="v3-media-wrap"> <div class="v3-visual-image" style="aspect-ratio:1264/710"> <a href="https://youtu.be/AbjrOnQEx-o" class="is-modal "> <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/04/medicenna-poster-1264x710-c-top.webp" width="1264" height="710" class="" alt="Best-in-class Expertise" loading="auto" /> </picture> <span class="bt-play-small" aria-hidden="true"> </span> </a> </div> </div> </div> <div class="mt-5"> <h3 class="hh3"><span class="text-brand-blue">Best-in-class Expertise</span></h3> </div> <p><span class="text-nutral-70" style="font-weight: 400;">Our highly-qualified Synthetic Control Arm team includes former members of FDA, Pharma, and the research community with regulatory, biostatistics, data science and medical oncology expertise. </span></p> <p><span class="text-nutral-70" style="font-weight: 400;">We work in collaboration alongside sponsors to design better trials, interact with regulators and accelerate development.</span></p> <div class="mt-auto"> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://youtu.be/AbjrOnQEx-o" target="_blank"> Watch Video </a> </div> </div> </div> </div> <div class="ui-panel p-6 mb-5 a" id="3"> <button class="ui-ac-bar ui-title dark p-0"> <b class="hh5">Synthetic Control Arm</b> <span>Expand</span> </button> <div class="ui-ac-body"> <div class="mt-5"> <div class="v3-media-wrap"> <div class="v3-visual-image" style="aspect-ratio:1264/710"> <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/10/MEDI_IE_web_keyfeatures-1264x710-c-top.webp" width="1264" height="710" class="" alt="Synthetic Control Arm" loading="auto" /> </picture> </div> </div> </div> <div class="mt-5"> <h3 class="hh3"><span class="text-brand-blue">Synthetic Control Arm</span></h3> </div> <p><span class="text-nutral-70" style="font-weight: 400;">Medidata AI Synthetic Control Arm has been a pioneer in defining adequate external controls and creating fit-for-purpose external controls for regulatory conversations and internal decision-making. Cohorts are built using patients drawn from previous clinical trials and selected by extracting patient-level data from the same indication, who met key eligibility criteria and were assigned to receive the standard of care. Statistical methods are then applied in a dynamic matching process that uses the baseline demographics and disease characteristics for each patient in the experimental trial to generate a historical patient group that closely matches the experimentally treated patients.</span></p> <div class="mt-auto"> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://assetlibrary.medidata.com/m/14ab23a8aaa2f74/original/Friends-of-Cancer-Research-White-Paper-Non-Small-Cell-Lung-Cancer-Sep-22.pdf" target="_blank"> View White Paper </a> </div> </div> </div> </div> <div class="ui-panel p-6 mb-5 a" id="4"> <button class="ui-ac-bar ui-title dark p-0"> <b class="hh5">Integrated with Real World Data</b> <span>Expand</span> </button> <div class="ui-ac-body"> <div class="mt-5"> <div class="v3-media-wrap"> <div class="v3-visual-image" style="aspect-ratio:1264/710"> <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/09/CT-RWD-Patient-1264x710-c-top.webp" width="1264" height="710" class="" alt="Integrated with Real World Data" loading="auto" /> </picture> </div> </div> </div> <div class="mt-5"> <h3 class="hh3"><span class="text-brand-blue">Integrated with Real World Data</span></h3> </div> <p class="text-nutral-70">Future-proof your clinical trial and enhance your evidence generation activities. Allow sponsors to collect clinical trial data and link it at the patient level to real world data (RWD) — bridging evidence gaps to save time and feel more confident in their decision making.</p> <div class="mt-auto"> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://www.medidata.com/wp-content/uploads/2024/08/Medidata-Link-Factsheet-May-24.pdf" target="_blank"> View Factsheet </a> </div> </div> </div> </div> </div> </div> </section> <section class="com v3-tabs-media v3 ui-ta"> <div class="v3-wrap py-120px row" > <div class="a v3-header col-xs-12 row w-full"> <div class="col-xs-12 col-sm-8"> <div class="mb-4 "> <h2 class="h-lg hh2"><span class="text-brand-blue">Resources</span></h2> </div> <div class="bt mb-1 "> </div> </div> </div> <div class="col-xs-12 !hidden md:!flex mt-[30px]"> <div class="v3-h-tabs"> <a href="#white-paper-mit-technology-review" class="ui-tab noscroll is-active"> White Paper: MIT Technology Review </a> <a href="#white-paper-make-evidence-based-decisions" class="ui-tab noscroll "> White Paper: Make evidence-based decisions </a> </div> </div> <div class="ui-panels"> <div id="white-paper-mit-technology-review" class="ui-panel is-active"> <button class="md:!hidden ui-ac-bar ui-title dark col-xs-12" data-hash="#white-paper-mit-technology-review"> White Paper: MIT Technology Review <span>Expand</span> </button> <div class="ui-ac-body"> <section class="com v3-media-mod v3" > <div class="row" > <div class="a2 md-media col-xs-12 col-sm-10 col-md-6"> <div class="v3-media-wrap"> <div class="v3-visual-image" > <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/08/MIT-Tech-Review-Thumbnail-1-1264x710-c-top.webp" width="1264" height="710" class="" alt="" loading="auto" /> </picture> </div> </div> </div> <div class="a md-text col-xs-12 col-sm-10 col-md-6 "> <div class="text-white mt-3 lg:mt-0"> <h3 class="hh3"><span class="text-brand-blue">White Paper: MIT Technology Review</span></h3> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70">Download this white paper, in partnership with MIT Technology Review, to learn how Celsion leverages Medidata’s detailed information from 23,000+ trials and 7 million patients to create “external control arms” and speed up the clinical trial <strong><a href="https://www.medidata.com/en/clinical-trial-products/acorn-ai/real-world-data">process</a></strong>.</span></p> </div> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://assetlibrary.medidata.com/m/a27a1aca480b9f3/original/MIT-Tech-Review-Clinical-trials-are-better-faster-cheaper-with-big-data.pdf" target="_blank"> White Paper: Synthetic Control Arm </a> </div> </div> </div> </section> </div> </div> <div id="white-paper-make-evidence-based-decisions" class="ui-panel "> <button class="md:!hidden ui-ac-bar ui-title dark col-xs-12" data-hash="#white-paper-make-evidence-based-decisions"> White Paper: Make evidence-based decisions <span>Expand</span> </button> <div class="ui-ac-body"> <section class="com v3-media-mod v3" > <div class="row" > <div class="a2 md-media col-xs-12 col-sm-10 col-md-6"> <div class="v3-media-wrap"> <div class="v3-visual-image" > <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/08/Intelligent-Trials-Clinican-ipad-1264x710-c-top.webp" width="1264" height="710" class="" alt="" loading="auto" /> </picture> </div> </div> </div> <div class="a md-text col-xs-12 col-sm-10 col-md-6 "> <div class="text-white mt-3 lg:mt-0"> <h3 class="hh3"><span class="text-brand-blue">White Paper: Go/No Go Product Development Decisions by Reusing Patient Trial Data</span></h3> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70">Learn how synthetic controls enable new insights for oncology clinical development and mitigates go/no-go decision risk.</span></p> </div> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://assetlibrary.medidata.com/m/63784f97bde5131a/original/White-Paper-De-Risk-GoNo-Go-Product-Development-Decisions-by-Reusing-Patient-Trial-Data_UpdatedJune2019.pdf" target="_blank"> Download White Paper </a> </div> </div> </div> </section> </div> </div> </div> </div> </section> <section class="com v3-list-cards v3" > <div class="v3-wrap row" > <div class="a v3-header col-xs-12 row w-full"> <div class="col-xs-12 col-sm-8"> <div class="mb-4 "> <h2 class="h-lg hh2"><span class="text-brand-blue">Related Solutions</span></h2> </div> <div class="bt mb-1 "> </div> </div> </div> <div class="col-xs-12 v3-cards mt-4"> <div class="card-list row"> <div class="a col-xs-12 col-sm-6 col-md-4 pb-[40px]"> <a href="https://www.medidata.com/en/clinical-trial-products/medidata-ai/real-world-data/synthetic-control-arm/" class="v3-card "> <div class="v3-media"> <div class="media-aspect"> <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/10/MEDI_IE_web_solutions_1-816x0-c-top.webp" width="816" height="" class="" alt="" loading="auto" /> </picture> <span class="bt-play-small bt-play-card" aria-hidden="true"></span> </div> </div> <div class="v3-card-content "> <div class="bt-xsmall text-nutral-70"> </div> <h2 class="hh5 !text-nutral-100"> Synthetic Control Arm<sup>®</sup> </h2> <div class="mt-auto"> <div class="card-bottom bt-xsmall leading-5 tracking-wide text-nutral-70"> SCA® offers the only external control group created with cross-industry historical trial data. Careful selection of patient level data yields a baseline composition that is statistically well balanced with the experimental arm to create an accurate synthetic control group. </div> <span class="cta-fake">Learn More</span> </div> </div> </a> </div> <div class="a col-xs-12 col-sm-6 col-md-4 pb-[40px]"> <a href="https://www.medidata.com/en/clinical-trial-products/medidata-ai/real-world-data/clinical-trial-design-software/" class="v3-card "> <div class="v3-media"> <div class="media-aspect"> <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/10/MEDI_IE_web_solutions_2-816x0-c-top.webp" width="816" height="" class="" alt="" loading="auto" /> </picture> <span class="bt-play-small bt-play-card" aria-hidden="true"></span> </div> </div> <div class="v3-card-content "> <div class="bt-xsmall text-nutral-70"> </div> <h2 class="hh5 !text-nutral-100"> Trial Design </h2> <div class="mt-auto"> <div class="card-bottom bt-xsmall leading-5 tracking-wide text-nutral-70"> Generate evidence and identify relevant data points from historical clinical trials that can serve as “ground truth” for regulatory submissions or for designing your clinical development programs. Run scenarios to identify the right data points to optimize your clinical trial design. Reduce uncertainty, reduce timelines, get to go/no-go decisions faster. </div> <span class="cta-fake">Learn More</span> </div> </div> </a> </div> <div class="a col-xs-12 col-sm-6 col-md-4 pb-[40px]"> <a href="https://www.medidata.com/en/clinical-trial-products/medidata-ai/real-world-data/link-real-world-and-clinical-trial-data/" class="v3-card "> <div class="v3-media"> <div class="media-aspect"> <picture class="image-media image-media-aspect w-full"> <img decoding="async" src="https://www.medidata.com/wp-content/uploads/2021/10/MEDI_IE_web_solutions_3-816x0-c-top.webp" width="816" height="" class="" alt="" loading="auto" /> </picture> <span class="bt-play-small bt-play-card" aria-hidden="true"></span> </div> </div> <div class="v3-card-content "> <div class="bt-xsmall text-nutral-70"> </div> <h2 class="hh5 !text-nutral-100"> Medidata Link </h2> <div class="mt-auto"> <div class="card-bottom bt-xsmall leading-5 tracking-wide text-nutral-70"> Future-proof your clinical trial and enhance your evidence generation activities with Medidata Link, which allows sponsors to collect clinical trial data and link it at the patient level to real world data (RWD). 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