GDPR Compliance for Clinical Trials

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class="vs-wrapper-main overflow-hidden "> <nav class="verasafe-breadcrumbs bg-green text-white"> <div class="verasafe-breadcrumbs-container container mx-auto overflow-hidden px-v_column_spacing"> <div class="flex -mx-v_column_spacing"> <div class="verasafe-breadcrumbs-content w-full px-v_column_spacing py-3 relative"> <span property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" href="https://verasafe.com" class="home" ><span property="name">Home</span></a><meta property="position" content="1"></span> <span class="breadcrumbs-separator"><i class="breadcrumbs-separator-icon"></i></span><span property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" title="Go to Privacy Solutions." href="/privacy-solutions/" class="home" ><span property="name">Privacy Solutions</span></a><meta property="position" content="2"></span> <span class="breadcrumbs-separator"><i class="breadcrumbs-separator-icon"></i></span><span class="post post-services current-item">GDPR Compliance Services for Clinical Trials</span> </div> </div> </div> </nav> <header class="verasafe-narrow-header overflow-hidden flex items-center"> <div class="verasafe-narrow-header-container w-full relative flex items-center mx-auto with-shading bg-center"> <div class="verasafe-narrow-header-inner container mx-auto px-v_column_spacing z-10"> <div class="flex -mx-v_column_spacing"> <div class="w-full px-v_column_spacing py-v_column_spacing_2x "> <div class="narrow-header-icon-and-title flex -mx-v_column_spacing md:items-center"> <div class="narrow-header-title-and-subtitle w-auto pl-v_column_spacing pr-v_column_spacing "> <h1 class="narrow-header-title text-mobile_h2 leading-mobile_h2 sm:text-h2 sm:leading-h2 text-white font-bold mb-0"> GDPR Compliance Services for Clinical Trials </h1> <p class="narrow-header-subtitle hidden tablet:block text-base sm:text-h5 leading-6 sm:leading-h5 text-white font-light mt-5 mb-5 xs:mt-v_body_small xs:mb-0 "> Leverage VeraSafe’s deep experience advising sponsors of EU clinical trials </p> </div> </div> <p class="narrow-header-subtitle block tablet:hidden text-base sm:text-h5 leading-6 sm:leading-h5 text-white font-light mt-5 mb-5 xs:mt-v_body_small xs:mb-0 "> Leverage VeraSafe’s deep experience advising sponsors of EU clinical trials </p> </div> </div> </div> </div> </header> <div id="vue-blue-contact-box" class=" vs-sticky-container with-blue-box-contact-dangling " > <div > <div class="vs-stylized-intro bg-secondary_bg py-v_column_spacing_2x"> <div class="container mx-auto px-v_column_spacing"> <div class="vs-stylized-intro-inner flex flex-wrap -mx-v_column_spacing"> <div class=" w-full lg:w-3/4 vs-stylized-intro-content-container px-v_column_spacing vs-stylized-intro-body"> <div class="vs-stylized-intro-content"> <p>VeraSafe provides a complete solution to ensure that your clinical trial is conducted in compliance with the EU General Data Protection Regulation (“GDPR”). Through numerous successful GDPR implementations ranging from small single-site phase I trials, to large multi-site phase III trials that involve clinical sites in multiple EU member states, VeraSafe has developed a highly specialized practice at the intersection of clinical trials and the GDPR.</p> <p>Take the first step now by contacting VeraSafe for a no-obligation quote.</p> </div> </div> <div class="w-full lg:w-1/4 lg:block px-v_column_spacing mt-v_column_spacing_2x lg:my-0 py-v_column relative z-10"> <div class="vs-sticky-box-container-outer relative"> <div class="vs-sticky-box-container relative" > <div class="widget-container widget-form"> <div class="widget-inner"> <div class="widget-content"> <script> window.hsFormsOnReady = window.hsFormsOnReady || []; window.hsFormsOnReady.push(()=>{ hbspt.forms.create({ portalId: 39943027, formId: "ee9a7be9-781b-4d05-947c-3a3bd30568b2", target: "#hbspt-form-1740505891000-3378791424", region: "na1", })}); </script> <div class="hbspt-form" id="hbspt-form-1740505891000-3378791424"></div> </div> <div class="widget-success"> <div class="vs-block-thank_you_message"> <div class="vs-block-thank_you_message-inner container mx-auto"> <div class="image"> <img class="inline-block" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/icon-thank_you2.svg" alt="Thank You"> </div> <div class="content"> <div class="heading mt-v_spacing_40"> <h2>Thank You!</h2> </div> <div class="text mt-v_spacing_5"> <p>We’ll be in contact shortly.</p> </div> <div class="buttons mt-v_spacing_25 flex items-center mt-v_button_spacing"> <button id="widget-success-close" class="widget-success-close btn mr-2 sm:mr-v_column_spacing_2x btn-primary btn-white btn-tall button-single" onClick="window.location.reload();" > Submit again </button> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="container mx-auto px-v_column_spacing pt-v_section_spacing pb-v_section_spacing"> <div class="flex -mx-v_column_spacing"> <div class="w-full px-v_column_spacing"> <div class="vs-block-text-in-flex " id="block_95974d55ce1d319a4a338c337e7d5ab8"> <div class="vs-block-text-in-flex-inner w-full lg:w-3/4"> <h2 class="text-h3 leading-h3">We’re Your Partner for Clinical Trials Under the GDPR</h2> <p>As part of VeraSafe’s expertise in this specialized area of law, our team is highly experienced in steering clinical trials through the requirements of not only the GDPR, but also local EU member-state legislation and regulatory guidance. VeraSafe also has specific expertise in managing the interplay between the GDPR, the EU Clinical Trial Regulation (“CTR”), and Good Clinical Practice guidelines (“GCP”). Rely on our expertise gained serving as the Data Protection Officer for numerous prominent pharmaceutical companies for assurance that your clinical trial will be GDPR compliant.</p> </div> </div> <div class="vs-block-remspacer mt-v_spacing_20 lg:mt-v_spacing_50 " id="block_d68b508722bc18d4eaf3fea64adecbfc"></div> <h2 class="wp-block-heading text-h3 leading-h3">Our Services Include:</h2> <div class="vs-block-services-include-list " id="block_093548b0c8e91105b3b8e4ff63be0b95"> <ul class="vs-block-services-include-list-lister flex flex-wrap -mx-v_column_spacing"> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-scoping-and-data-mapping"> <i class="align-middle vsicon vsicon-DataMapping text-icon_32" style="color: #f44336"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Scoping and Data Mapping</span> <span class="mouse-info hidden md:block"><img decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Scoping and Data Mapping"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-data-protection-impact-assessments"> <i class="align-middle vsicon vsicon-DataProtectionImpactAssessments text-icon_32" style="color: #03a9f4"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Data Protection Impact Assessments</span> <span class="mouse-info hidden md:block"><img decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Data Protection Impact Assessments"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-informed-consent-forms-review-and-revision"> <i class="align-middle vsicon vsicon-ConsentFormsReview text-icon_32" style="color: #e91e63"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Informed Consent Forms Review and Revision</span> <span class="mouse-info hidden md:block"><img decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Informed Consent Forms Review and Revision"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-internal-policy-and-procedure-review"> <i class="align-middle vsicon vsicon-DisputeResolutionProcedure text-icon_32" style="color: #00bcd4"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Internal Policy and Procedure Review</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Internal Policy and Procedure Review"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-privacy-notice-drafting"> <i class="align-middle vsicon vsicon-PrivacyNoticeDrafting text-icon_32" style="color: #aa00ff"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Privacy Notice Drafting</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Privacy Notice Drafting"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-data-subject-rights-management"> <i class="align-middle vsicon vsicon-DataSubjectRightsManagement text-icon_32" style="color: #00bfa5"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Data Subject Rights Management</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Data Subject Rights Management"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-vendor-management"> <i class="align-middle vsicon vsicon-VendorManagement text-icon_32" style="color: #7c4dff"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Vendor Management</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Vendor Management"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-it-security-review-and-remediation"> <i class="align-middle vsicon vsicon-ITSecurityReview text-icon_32" style="color: #8bc34a"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">IT Security Review and Remediation</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="IT Security Review and Remediation"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-clinical-trial-agreements"> <i class="align-middle vsicon vsicon-ClinicalTrialAgreements text-icon_32" style="color: #536dfe"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Clinical Trial Agreements</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Clinical Trial Agreements"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-data-protection-officer-services"> <i class="align-middle vsicon vsicon-Officer text-icon_32" style="color: #ff8f00"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Data Protection Officer Services</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Data Protection Officer Services"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-collaboration-partners"> <i class="align-middle vsicon vsicon-CollaborationPartners text-icon_32" style="color: #2196f3"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Collaboration Partners</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Collaboration Partners"></span> </a> </li> <li class=" vs-block-services-include-list-item mb-0 px-v_column_spacing w-full lg:w-1/2 cursor-pointer hover:shadow-v_hover_items rounded-vs_grid"> <a class="list-item-inner hash-disable relative flex" href="#services_lister-article-27-eu-data-protection-representative"> <i class="align-middle vsicon vsicon-Article27_6 text-icon_32" style="color: #ff5722"></i> <span class="align-middle list-item-title text-h4 leading-h4 font-medium font-display">Article 27 EU Data Protection Representative</span> <span class="mouse-info hidden md:block"><img loading="lazy" decoding="async" src="https://verasafe.com/wp-content/themes/verasafe/src/assets/img/mouse-icon.svg" width="32" height="32" alt="Article 27 EU Data Protection Representative"></span> </a> </li> </ul> </div> <div class="vs-block-remspacer mt-v_spacing_20 lg:mt-v_spacing_30 " id="block_243c03f1caba7b3dcfe652203ca8e073"></div> <section class="vs-block-colour-section w-full " id="block_5a90fc16769a4c283c3619278abacee9"> <div class=" make-full-width-inside-container text-white bg-green py-v_column_spacing_2x md:py-v_spacing_50"> <div class="container mx-auto px-v_column_spacing"> <div class="flex -mx-v_column_spacing"> <div class="w-full px-v_column_spacing"> <h3>VeraSafe’s Outstanding Legal Project Management Methodology</h3> <p>VeraSafe’s tried and proven project management methodology ensures that we are able to meet tight deadlines and accommodate aggressive study timelines. Your VeraSafe project team will include a qualified project manager who is responsible for managing the overall pace, organization, and efficiency of your compliance project. The project manager has the ability to draw on the resources and expertise of the entire VeraSafe team, when needed, to accelerate the completion of deliverables.</p> </div> </div> </div> </div> </section> <div class="vs-block-remspacer mt-v_spacing_20 lg:mt-v_spacing_30 " id="block_243c03f1caba7b3dcfe652203ca8e073"></div> <div class="vs-block-services-include-details " id="block_d530e1f30f792ec3abfa6246e4d9f48a"> <div class="vs-block-services-include-details-lister flex flex-wrap -mx-v_column_spacing"> <div class="px-v_column_spacing w-full lg:w-1/2"> <ul> <li id="services_lister-scoping-and-data-mapping" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-DataMapping text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Scoping and Data Mapping</span> </h3> <div class="details-content text-grey5"> <p>A foundational first step towards GDPR compliance is to develop your organization’s records of personal data processing activities. Article 30 of the GDPR requires study sponsors to maintain accurate records of their data processing activities. VeraSafe will assist your organization in developing these records and implementing internal processes to facilitate ongoing updates of such records.</p> </div> </div> </div> </li> <li id="services_lister-informed-consent-forms-review-and-revision" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-ConsentFormsReview text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Informed Consent Forms Review and Revision</span> </h3> <div class="details-content text-grey5"> <p>ICFs are often used as a venue to provide the requisite privacy notice (informally known as a “privacy policy”) to patients, as required by Articles 13 and 14 of the GDPR. These required disclosures can be made within the main body of the ICFs or can be relegated to an appendix or attachment to the ICFs (among other options). VeraSafe can review your ICF templates and revise them, as needed, to ensure compliance with Articles 13 and 14 of the GDPR. VeraSafe is sensitive to the requirement that ICFs be concise and written using plain language to ensure intelligibility by patients.</p> <p>VeraSafe can tailor ICFs on a country-by-country basis, according to member state guidance and local practice, such as where EU member states vary in their preference in terms of the sponsor’s lawful basis of processing personal data (per Articles 6 and 9 of the GDPR).</p> </div> </div> </div> </li> <li id="services_lister-privacy-notice-drafting" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-PrivacyNoticeDrafting text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Privacy Notice Drafting</span> </h3> <div class="details-content text-grey5"> <p>As an alternative to using ICFs as a means to provide the requisite privacy notice disclosures to patients, VeraSafe will draft a standalone privacy notice to enable your organization’s compliance with the privacy notice obligations of the GDPR. VeraSafe can review and revise your current patient privacy notice or create a new patient privacy notice for your clinical trial, as needed.</p> </div> </div> </div> </li> <li id="services_lister-vendor-management" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-VendorManagement text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Vendor Management</span> </h3> <div class="details-content text-grey5"> <p>The GDPR requires a written contract to be signed between your organization and each of its vendors that have the technical or physical ability to access clinical trial patient data or personal data of site staff. Such vendors typically include contract research organizations (“CROs”), labs, and cloud software providers, among others. Compliance with this obligation is most frequently accomplished by signing a data processing addendum (“DPA”) with such vendors.</p> <p> </p> <p>These DPAs must include a number of specific provisions to mandate that the technical and organizational measures by which the vendors secure personal data meet the high standards of the GDPR. VeraSafe will assist your organization in reviewing these vendor contracts and, if necessary, directly support or lead the effort to negotiate and sign a DPA with each of your organization’s relevant vendors.</p> </div> </div> </div> </li> <li id="services_lister-clinical-trial-agreements" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-ClinicalTrialAgreements text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Clinical Trial Agreements</span> </h3> <div class="details-content text-grey5"> <p>Much in the same way that your organization must implement DPAs with its vendors, a sponsor must ensure that clinical sites also are subject to a DPA. Data processing addenda can be attached to your clinical trial agreements that are signed by your clinical sites. The data protection terms contained within these DPAs can be made country-specific, e.g., depending on whether a clinical site is a processor or a controller in that jurisdiction.</p> </div> </div> </div> </li> <li id="services_lister-collaboration-partners" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-CollaborationPartners text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Collaboration Partners</span> </h3> <div class="details-content text-grey5"> <p>In case your clinical trial involves collaboration partners that receive study data (even key-coded data) outside of the European Economic Area (“EEA”), a specialized data transfer agreement may need to be implemented between your organization and the collaboration partner(s). VeraSafe will draft this data transfer agreement and, if necessary, assist your organization in negotiating and signing the agreement with your organization’s collaboration partner(s).</p> </div> </div> </div> </li> </ul> </div> <div class="px-v_column_spacing w-full lg:w-1/2"> <ul> <li id="services_lister-data-protection-impact-assessments" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-DataProtectionImpactAssessments text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Data Protection Impact Assessments</span> </h3> <div class="details-content text-grey5"> <p>Clinical trials in the EU inevitably involve processing personal health data, which must be archived for an especially long period of time in a clinical trial master file. For these reasons, a Data Protection Impact Assessment (“DPIA”) is typically required under the GDPR as part of a sponsor’s preparation for a clinical trial. In conducting your Data Protection Impact Assessment, VeraSafe will leverage its well-developed methodology and specialized templates specific to DPIAs for clinical trials.</p> </div> </div> </div> </li> <li id="services_lister-internal-policy-and-procedure-review" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-DisputeResolutionProcedure text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Internal Policy and Procedure Review</span> </h3> <div class="details-content text-grey5"> <p>A clinical trial sponsor’s internal policies and procedures typically require some level of revision to help ensure that business operations are aligned to the GDPR. To meet this challenge, VeraSafe has painstakingly developed a library of data protection-related standard operating procedure templates that can be easily customized to fit your particular circumstances. VeraSafe can also refine your existing policies and procedures to embed the requisite GDPR operational requirements into your existing business process documentation.</p> </div> </div> </div> </li> <li id="services_lister-data-subject-rights-management" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-DataSubjectRightsManagement text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Data Subject Rights Management</span> </h3> <div class="details-content text-grey5"> <p>In practice, a number of patient privacy rights established under the GDPR are effectively limited by countervailing obligations under the EU Clinical Trial Regulation. However, the sponsor must nevertheless ensure that patients have a means to request the exercise of their privacy rights. To comply with this requirement but avoid violating the confidentiality requirements of Good Clinical Practice guidelines, VeraSafe can serve as your organization’s point of contact for patients who wish to exercise privacy rights available to them under the GDPR.</p> </div> </div> </div> </li> <li id="services_lister-it-security-review-and-remediation" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-ITSecurityReview text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">IT Security Review and Remediation</span> </h3> <div class="details-content text-grey5"> <p>Article 32 of the GDPR establishes a broad requirement for strong data security in pursuit of overall privacy protection. If requested, VeraSafe can review your organization’s IT security policies and procedures against the VeraSafe Privacy Program Certification Criteria, which is a highly actionable set of requirements that merges the GDPR’s risk-based approach with the U.S. National Institute of Standards and Technology’s Cybersecurity Framework for Critical Infrastructure (“NIST CSF”). This data protection standard provides the basis of a high-assurance assessment of compliance with Article 32.</p> </div> </div> </div> </li> <li id="services_lister-data-protection-officer-services" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-Officer text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Data Protection Officer Services</span> </h3> <div class="details-content text-grey5"> <p>Clinical trial sponsors are typically subject to the GDPR’s requirement to appoint a Data Protection Officer (“DPO”). Appointing VeraSafe as your organization’s DPO is an exceptionally easy and cost-effective approach, which ensures your compliance with this important obligation.</p> <p>As your DPO, the entire VeraSafe team of privacy experts, in-house attorneys, IT security experts, and project managers will be available as your data protection subject matter experts. Going beyond the compliance activities described above, our team will help monitor your organization’s compliance with the Regulation and proactively identify compliance strategies, opportunities, and risks.</p> </div> </div> </div> </li> <li id="services_lister-article-27-eu-data-protection-representative" class="mb-v_spacing_20 lg:mb-v_spacing_40"> <div class="flex flex-wrap -mx-v_column_spacing align-middle"> <div class="lister-detail-icon w-1/6 px-v_column_spacing text-center xl:text-left"> <i class="vsicon vsicon-Article27_6 text-grey2 text-icon_32 xl:text-icon_64"></i> </div> <div class="lister-detail-content w-5/6 px-v_column_spacing"> <h3 class="align-middle list-item-title mb-v_spacing_20"> <span class="text-blue">Article 27 EU Data Protection Representative</span> </h3> <div class="details-content text-grey5"> <p>The GDPR requires many organizations that are regulated by the GDPR but that have no physical presence in the EU to appoint an official representative located in the EU for the purpose of responding to the inquiries of European regulatory agencies and data subjects.</p> <p>By appointing VeraSafe’s European subsidiary as your organization’s official EU representative for data protection, you can rest assured that your organization complies with this often-overlooked requirement.</p> </div> </div> </div> </li> </ul> </div> </div> </div> <section class="vs-block-colour-section w-full " id="block_89410050fe6885c000509a416388b333"> <div class=" make-full-width-inside-container text-black bg-grey1 py-v_column_spacing_2x md:py-v_spacing_50"> <div class="container mx-auto px-v_column_spacing"> <div class="flex -mx-v_column_spacing"> <div class="w-full px-v_column_spacing"> <h3 style="text-align: center; font-size: 30px; margin-top: 25px; padding-right: 25px; padding-left: 25px">What Our Clients Have to Say</h3> <div class="columns-with-image flex flex-wrap md:flex-no-wrap pb-v_column_spacing"> <div class="column-item text-sm text-center py-v_column_spacing_2x w-full xs:w-1/2 sm:w-1/3 md:w-auto md:flex-grow md:flex-basis-0"> <img decoding="async" class="mx-auto mb-v_spacing_30" src="" alt=""/> <p><p style="text-align: justify; text-align-last: left; padding-right: 25px; padding-left: 25px">“VeraSafe has been an invaluable partner to support our data privacy and data protection program at Vigil. They’ve been able to provide deep expertise in support of our global clinical trial activities and are an important part of our team.”</p><br /> <p style="text-align: left; padding-right: 25px; padding-left: 25px"><br /> <strong>Kevin Durfee, Head of Information Technology</strong><br /> Vigil Neuroscience<br /> </p></p> </div> <div class="column-item text-sm text-center py-v_column_spacing_2x w-full xs:w-1/2 sm:w-1/3 md:w-auto md:flex-grow md:flex-basis-0"> <img decoding="async" class="mx-auto mb-v_spacing_30" src="" alt=""/> <p><p style="text-align: justify; text-align-last: left; padding-right: 25px; padding-left: 25px">“We appointed VeraSafe as our Data Protection Officer to help us comply with data protection rules for our clinical trials in the EU. From the project kickoff, it was clear that we had made the right choice. VeraSafe’s deep knowledge of the regulation of clinical trials and the GDPR was immediately apparent. The advice we received was relevant, appropriate, and practical to implement within our organization and our clinical operations.”</p><br /> <p style="text-align: left; padding-right: 25px; padding-left: 25px"><br /> <strong>Founder and CEO</strong><br /> Biotech Specializing in Immunotherapy </p></p> </div> <div class="column-item text-sm text-center py-v_column_spacing_2x w-full xs:w-1/2 sm:w-1/3 md:w-auto md:flex-grow md:flex-basis-0"> <img decoding="async" class="mx-auto mb-v_spacing_30" src="" alt=""/> <p><p style="text-align: justify; text-align-last: left; padding-right: 25px; padding-left: 25px">“VeraSafe’s subject matter expertise in the regulation of clinical trials was relevant to our regulatory submissions and was apparent from the project kickoff and throughout the project. It has been a pleasure working with such professional, highly-qualified, and competent people.”</p><br /> <p style="text-align: left; padding-right: 25px; padding-left: 25px"><br /> <strong>VP Legal</strong><br /> Leading Oncology-Focused Biopharmaceutical</p></p> </div> </div> </div> </div> </div> </div> </section> </div> </div> </div> </div> </div> <div class="vs-section-blue text-white py-v_section_spacing" style=""> <div class="vs-bg-svg md:block"> <svg width="1440" height="187" viewBox="0 0 1406 187" fill="none" xmlns="http://www.w3.org/2000/svg"> <path opacity="0.11" d="M26 -104C26 -104.552 26.4477 -105 27 -105H226C226.552 -105 227 -104.552 227 -104V2.12987C227 45.4642 208.259 86.6811 175.603 115.167L173.172 117.288C146.43 140.615 106.57 140.615 79.8279 117.288L77.397 115.167C44.7409 86.6811 26 45.4642 26 2.12983V-104Z" stroke="#BEC7D7" stroke-width="51" stroke-linecap="round" stroke-linejoin="round"/> <path opacity="0.11" d="M1320 -31C1320 -31.5523 1320.45 -32 1321 -32H1457C1457.55 -32 1458 -31.5523 1458 -31V39.9592C1458 70.4772 1444.78 99.4981 1421.75 119.523V119.523C1402.97 135.853 1375.03 135.853 1356.25 119.523V119.523C1333.22 99.4981 1320 70.4772 1320 39.9592V-31Z" stroke="#BEC7D7" stroke-width="31" stroke-linecap="round" stroke-linejoin="round"/> <path opacity="0.11" d="M1155 88.9197C1155 88.4118 1155.41 88 1155.92 88H1228.08C1228.59 88 1229 88.4118 1229 88.9197V126.189C1229 142.58 1221.88 158.162 1209.48 168.884V168.884C1199.44 177.563 1184.56 177.563 1174.52 168.884V168.884C1162.12 158.162 1155 142.58 1155 126.189V88.9197Z" stroke="#BEC7D7" stroke-width="22" stroke-linecap="round" stroke-linejoin="round"/> </svg> </div> <div class="container mx-auto px-v_column_spacing"> <div class="flex flex-wrap -mx-v_column_spacing"> <div class="vs-faq px-v_column_spacing w-full"> <div class="vs-section-blue-outer"> <div class="vs-section-blue-inner"> <div class="container mx-auto overflow-hidden text-center"> <div class="text"> <h2 class="mb-v_spacing_20 big">Schedule an Introductory Call</h2> </div> <div class="text text-subheading-container pb-v_column_spacing_2x"> <h3 class="h4 ">Whether your organization is sponsoring a single phase I study, multiple phase III studies, or something in between, VeraSafe is your ideal partner in navigating the complexities of designing and operating clinical trials in compliance with the GDPR.</h3> </div> <div class="buttons-container flex flex-wrap md:flex-no-wrap justify-center"> <div class="button button_normal"> <a class="w-full block btn btn-primary btn-wide btn-orange rounded mx-auto" href="/about-us/free-consultation/" aria-label="Get started">Get started</a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <section class="vs-section-why-verasafe py-v_column_spacing_2x md:py-v_section_spacing bg-secondary_bg"> <div class="vs-section-why-verasafe-inner"> <div class="container mx-auto overflow-hidden px-v_column_spacing"> <header class="verasafe-header-with-subheader mb-8 md:mb-10"> <h2 class="text-center text-mobile_h3 leading-mobile_h3 sm:text-h2 sm:leading-h2 mb-v_spacing_10 "> Why VeraSafe? 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