Trust and Transparency | Medidata Unified Protection Strategy

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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 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 menu-item-type-custom menu-item-object-custom 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</div> </header> <div class="content-wrap"> <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/2022/04/unified-protection-strategy-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">Leading With Trust and Transparency</span></h1> <h2 class="h-md hh2"><span class="text-brand-blue">Medidata’s Unified Protection Strategy</span></h2> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70" style="font-weight: 400;">Medidata’s Unified Protection Strategy encompasses our secure, stable, and scalable cloud platform, robust data governance processes, and an inspection-ready quality management system – all critical enablers to successful clinical trial execution. Our Information Security, Privacy, and Quality Management teams work in unison to safeguard your data and provide solutions that ensure your regulatory compliance.</span></p> <p><span class="text-nutral-70" style="font-weight: 400;">The foundational element of the Unified Protection Strategy is transparency in our business processes. From numerous third-party attestations and certifications that assess and validate our systems to comprehensive insights into our software development life cycle, the business transparency that Medidata provides has been earning your trust for more than 20 years.</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">The Unified Protection Strategy</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="#quality-management" class="ui-tab noscroll is-active"> Quality Management </a> <a href="#privacy" class="ui-tab noscroll "> Privacy </a> <a href="#information-security" class="ui-tab noscroll "> Information Security </a> </div> </div> <div class="ui-panels"> <div id="quality-management" class="ui-panel is-active"> <button class="md:!hidden ui-ac-bar ui-title dark col-xs-12" data-hash="#quality-management"> Quality Management <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/2022/04/medidata-regulatory-compliance-quality-management-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"> <h2 class="hh2"><span class="text-brand-blue">A Trusted Advisor and Compliance Champion</span></h2> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70" style="font-weight: 400;">Medidata’s Quality Management experts are trusted advisors to the life sciences industry. We provide insights into existing and potential regulatory policy, influence regulatory strategy in conjunction with governing bodies, and advocate for our customers. Additionally, we maintain a robust and inspection-ready Quality Management System inclusive of policies and procedures to ensure that our products and services are developed, implemented, and maintained in a manner that exceeds your expectations and assures compliance with regulatory requirements.</span></p> </div> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://learn.medidata.com/en-US/bundle/regulatory-compliance/page/medidata_s_position__guideline_for_computerised_systems_and_electronic_data_in_clinical_trials.html" target="_blank"> Medidata’s Position: Guideline for Computerized Systems and Electronic Data in Clinical Trials </a> <a class="bt-blue" href="https://www.medidata.com/en/medidatas-statement-on-fda-eres-2024-guidance/" target="_blank"> Medidata’s Statement on FDA ERES 2024 Guidance </a> </div> </div> </div> </section> </div> </div> <div id="privacy" class="ui-panel "> <button class="md:!hidden ui-ac-bar ui-title dark col-xs-12" data-hash="#privacy"> Privacy <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/2022/04/medidata-protects-pii-information-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"> <h2 class="hh2"><span class="text-brand-blue">Safeguarding Your Data</span></h2> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70" style="font-weight: 400;">Your data privacy is safeguarded through Medidata’s integrated data governance program designed to ensure oversight and accountability. Medidata aligns with all regulatory data standards and adapts in real-time to ensure your compliance. Our commitment to data privacy shows – Medidata was one of the first life sciences companies to achieve ISO 27018 certification for protecting Personally Identifiable Information (PII) in the cloud.</span></p> </div> <div class="pt-2 v3-button-wrap a" > </div> </div> </div> </section> </div> </div> <div id="information-security" class="ui-panel "> <button class="md:!hidden ui-ac-bar ui-title dark col-xs-12" data-hash="#information-security"> Information Security <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/2022/04/medidata-security-threat-analysis-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"> <h2 class="hh2"><span class="text-brand-blue">Providing a Stable and Secure Platform</span></h2> </div> <div class="bt text-white mb-5"> <p><span class="text-nutral-70" style="font-weight: 400;">Medidata’s Security Control Mapping Topic Guide provides a clear view of how we align our security practices with industry standards. It outlines the frameworks and controls we follow to protect our customers data, offering transparency into our approach to trust and compliance. This guide is part of our commitment to safeguarding your information with integrity and accountability.</span></p> </div> <div class="pt-2 v3-button-wrap a" > <a class="bt-blue" href="https://www.medidata.com/wp-content/uploads/2024/11/Medidata_Topic-Guide_v1.2_20241021.pdf" target="_blank"> Medidata’s Security Control Mapping Topic Guide </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">Our Accreditations and Certifications</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">Accreditations & Certifications</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/2022/04/Medidata_Trust_Transparency_keyfeatures_A1-1264x710-c-top.webp" width="1264" height="710" class="" alt="Accreditations & Certifications" loading="auto" /> </picture> </div> </div> </div> <div class="mt-5"> <h2 class="hh2"><span class="text-brand-blue">Accreditations & Certifications</span></h2> </div> <p><span class="text-nutral-70"><span style="font-weight: 400;">The </span><a href="https://www.medidata.com/en/clinical-trial-products/unified-platform" target="_blank" rel="noopener"><span style="font-weight: 400;">Medidata Platform</span></a><span style="font-weight: 400;">, Medidata’s unified platform, is built to protect your data’s privacy, security, and quality. These critical elements are built in at the design phase of our technology. This validated core is certified by multiple independent authorities to reinforce this commitment.</span><span style="font-weight: 400;"> </span></span></p> <p><span class="text-nutral-70" style="font-weight: 400;">Medidata’s robust accreditation and certification portfolio defines our industry’s gold standards around information security, patient data privacy, and quality management.</span></p> </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">Data Privacy</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/2022/04/Data-Privacy-1264x710-c-top.webp" width="1264" height="710" class="" alt="Data Privacy" loading="auto" /> </picture> </div> </div> </div> <div class="mt-5"> <h2 class="hh2"><span class="text-brand-blue">Data Privacy</span></h2> </div> <p><span class="text-nutral-70" style="font-weight: 400;">In addition to our robust GDPR compliance program, Medidata achieved one of the first independent ISO certifications for Privacy and for Service Organization Control 2 (SOC2) over Privacy. </span></p> <p><span class="text-nutral-70" style="font-weight: 400;">Privacy protection is built into the entire service lifecycle at Medidata. From our GDPR-ready Data Processing Exhibit and integrated Privacy-by-Design to our industry-leading Data Governance program, Medidata is committed to accountability for how we steward your sensitive clinical trial data anywhere on our platform.</span></p> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://learn.medidata.com/en-US/bundle/medidata-clinical-cloud-releases/page/medidata_gdpr_data_processing_documentation.html">Data Processing Exhibit </a><a class="is-modal" href="https://learn.medidata.com/en-US/bundle/medidata-clinical-cloud-releases/page/medidata_gdpr_data_processing_documentation.html"><img decoding="async" class="icon alignnone" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" alt="" width="80" height="41" /></a></span></div> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://www.medidata.com/wp-content/uploads/2023/10/GDPR_SCCs-DPE-Information-Sheet-2023.pdf" target="">DPE and SCC Information Sheet<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /> </a></span></div> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://learn.mdsol.com/mcc/files/132326650/295377719/1/1628210058241/Medidata+SCC+Transfer+Impact+Whitepaper+%28July+2021%29.pdf" target="">SCC Transfer Impact Whitepaper<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /> </a></span></div> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://learn.medidata.com/en-US/bundle/medidata-clinical-cloud-releases/page/medidata_subprocessors_list.html" target="">Subprocessors List<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /> </a></span></div> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://www.medidata.com/wp-content/uploads/2022/10/ISO-27018-SOC-10014794-EN.pdf" target="">ISO 27018:2019 Statement of Conformity<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /></a></span></div> <div> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://www.medidata.com/wp-content/uploads/2022/10/27701-and-27001-Certificates.pdf" target="">ISO 27701:2019 Certificate<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /></a></span></div> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://learn.medidata.com/en-US/bundle/medidata-clinical-cloud-releases/page/china_data_processing_documentation_and_information.html">China Data Processing Documentation and Information<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /></a></span></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">Quality Management</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/2022/04/Data-Quality-1-1264x710-c-top.webp" width="1264" height="710" class="" alt="Quality Management" loading="auto" /> </picture> </div> </div> </div> <div class="mt-5"> <h2 class="hh2"><span class="text-brand-blue">Quality Management</span></h2> </div> <p><span class="text-nutral-70" style="font-weight: 400;">The <a href="https://www.medidata.com/wp-content/uploads/2022/12/Global-Compliance-Strategy-Fact-Sheet-OCT-22.pdf">Quality Management team</a> provides you with visibility into our robust governance, risk, and compliance environment. In addition to our various security and privacy-related accreditations and certifications, Medidata publishes a voluntary Service Organization Control report (SOC2+), conducted biannually by PricewaterhouseCoopers. This critical report covers the following areas:</span></p> <ul> <li style="font-weight: 400;" aria-level="1"><span class="text-nutral-70" style="font-weight: 400; font-size: 16px;">Medidata’s Quality Management System</span></li> <li style="font-weight: 400;" aria-level="1"><span class="text-nutral-70" style="font-weight: 400; font-size: 16px;">Security (e.g., physical, logical)</span></li> <li style="font-weight: 400;" aria-level="1"><span class="text-nutral-70" style="font-weight: 400; font-size: 16px;">IT Hosting operations (e.g., system monitoring, disaster recovery)</span></li> <li style="font-weight: 400;" aria-level="1"><span class="text-nutral-70" style="font-weight: 400; font-size: 16px;">Software Development Life Cycle</span></li> <li style="font-weight: 400;" aria-level="1"><span class="text-nutral-70" style="font-weight: 400; font-size: 16px;">Data Integrity (e.g., Electronic Record/Electronic Signatures)</span></li> </ul> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://learn.medidata.com/en-US/bundle/medidata-clinical-cloud-releases/page/about_global_compliance___strategy__gcs_.html" target="">SOC2+<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /></a></span></div> <div class=" btn"><span class="text-nutral-70"><a class="is-modal" tabindex="0" href="https://assetlibrary.medidata.com/m/5ab480b2e672a075/original/tg-SOC2-Type-II-Report-221010.pdf" target="">SOC2+ Report Topic Guide<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /></a></span></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">Information Security</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/2022/04/Data-Security-1264x710-c-top.webp" width="1264" height="710" class="" alt="Information Security" loading="auto" /> </picture> </div> </div> </div> <div class="mt-5"> <h2 class="hh2"><span class="text-brand-blue">Information Security</span></h2> </div> <p><span style="font-weight: 400;">Data security at Medidata is the highest priority. We lead the industry in security and compliance using state-of-the-art technology and techniques, coupled with a strategy that supports our scalable, secure and stable environment, Medidata holds over twelve security certifications, six agency certifications, and built on four highly valued frameworks. We continuously improve our security capabilities and educate our workforce with the latest techniques to protect all of your clinical study data.</span></p> <div class=" btn"><a class="" tabindex="0" href="https://assetlibrary.medidata.com/m/2324d759405897c6/original/Security-Whitepaper-8-19-22.pdf" target="_blank" rel="noopener">Information Security Whitepaper (EN)<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /> </a></div> <div class=" btn"><a class="" tabindex="0" href="https://www.medidata.com/wp-content/uploads/2024/06/WHITEPAPER-Security-V3_Japanese-Japan.pdf" target="_blank" rel="noopener">Information Security Whitepaper (JP)<img decoding="async" class="icon" style="width: 30px; height: auto;" src="https://www.medidata.com/wp-content/uploads/2021/06/em_black_arrow.png" /></a></div> <div class="btn"><a class="" tabindex="0" 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