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href="https://arkivum.com/corporate-records-archives/">Find out more</a></div></div></div></div></li><li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-39"> <a href="https://arkivum.com/solution/">Solution</a><div class="mega-menu absolute top-full left-0 right-0 bg-black text-white border-y-2 border-white/10 py-12"><div class="container"><div class="flex gap-x-10 xl:gap-x-20"><div class="max-w-[300px]"> <span class="text-2xl mb-5 font-bold block">Key features of our archive solution </span> <a href="https://arkivum.com/solution/" class="y-btn inline-block">Overview</a></div><div class="grid grid-cols-3 w-full gap-x-10 xl:gap-x-20 gap-y-6 "><div class="mega-menu-grid-item relative after:absolute after:inset-y-0 after:w-0.5 after:bg-white/10 after:-right-5 xl:after:-right-10 last:after:hidden"> <a href="https://arkivum.com/safeguarding/" class="text-white hover:text-green"> <span class="text-lg font-bold block mb-4">Safeguarding</span><p 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mb-4">Migration Service</span><p class="text-base font-light text-grey-v-light">End-to-end data migration service with minimal customer input</p> </a></div><div class="mega-menu-grid-item relative after:absolute after:inset-y-0 after:w-0.5 after:bg-white/10 after:-right-5 xl:after:-right-10 last:after:hidden"> <a href="https://arkivum.com/ingestiq/" class="text-white hover:text-green"> <span class="text-lg font-bold block mb-4">IngestIQ</span><p class="text-base font-light text-grey-v-light">Migration in minutes, at scale</p> </a></div></div></div></div></div></li><li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-40"> <a href="https://arkivum.com/case-studies/">Case Studies</a></li><li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-182"> <a href="https://arkivum.com/resources/">Resources</a><div class="mega-menu absolute top-full left-0 right-0 bg-black text-white border-y-2 border-white/10 py-12"><div 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breadcrumb-text-white" id="breadcrumb"><span><span><a href="https://arkivum.com/">Home</a></span> <i class="breadcrumb-separator bg-center bg-no-repeat bg-12px h-2.5 w-2.5 inline-block px-1.5"></i> <span><a href="https://arkivum.com/pharmaceutical-life-sciences/">Pharmaceutical & Life Sciences</a></span> <i class="breadcrumb-separator bg-center bg-no-repeat bg-12px h-2.5 w-2.5 inline-block px-1.5"></i> <span class="breadcrumb_last" aria-current="page">eTMF and Clinical Trial</span></span></div><h1 class="text-hero-sm-mob md:text-hero-sm text-white mb-5 font-semibold">The Only Validated GCP Archiving and Preservation Solution</h1></div></div><section class="relative md:h-[120px] "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-white"></div><div class="relative stream-wrapper"> <svg class="w-full h-60px md:h-120px object-cover " fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#00D48C"/> </svg></div></section></section><section id="" class="scroll-mt-230px md:scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-white wp-elements-7a9726d1c6ee633a254105fb5644e5a7"><div class="container text-left" data-aos="fade-in"><h2 class="mb-5 text-2xl md:text-4xl font-extrabold text-black">Data Retention: Compliance is complex. Complying doesn’t have to be.</h2><div class="content-wrapper mb-5 text-black content-black" ><p>Clinical trial sponsors face a complex regulatory landscape, especially when it comes to data retention. Regulations such as EU CTR state that your eTMF needs to be retained for 25 years or more. Data must be accessible and legible throughout that period.</p><p>And that’s before you’ve considered the long-term needs for other clinical data, such as eCRF, eCOA and ePRO.</p><p>As part of a risk-based approach it is essential that you select a GCP compliant archive and preservation solution, enabling you to maintain data integrity in line with ALCOA+ throughout the entire clinical data lifecycle. This supports compliance with regulations and guidelines such as EU CTR, FDA CFR 21 Part 11 and ICH E6 R3.</p><blockquote><p><em>“The content of the clinical trial master file shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities.</em>”</p></blockquote><p><span style="font-weight: 400;">EU Regulation 536 of the European Parliament</span></p></div></div></section><section class="relative md:h-[120px] "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-white"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-black"></div><div class="relative stream-wrapper"> <svg class="w-full h-60px md:h-120px object-cover -scale-y-100" fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#050505"/> </svg></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-black wp-elements-172d7a24f8ec220e15ba514308f5176d"><div class="container"><div class="grid lg:grid-cols-2 gap-10 xl:gap-20"><div class="relative lg:order-1" data-aos="fade-in"><div class="lg:absolute inset-0 rounded-5px overflow-hidden h-600px lg:h-full"> <img decoding="async" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAABAAAAAMAAQMAAACAdIdOAAAABlBMVEUAAAD///+l2Z/dAAAAAXRSTlMAQObYZgAAAAlwSFlzAAAOxAAADsQBlSsOGwAAAHZJREFUeNrtwQEBAAAAgiD/r25IQAEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAO8Ggw8AAeUA3VQAAAAASUVORK5CYII=" height="1440" width="1920" alt="Arkivum image" class="size-full object-cover lazyload" data-src="https://arkivum.com/app/uploads/2024/07/7-1024x768.jpg" data-srcset="https://arkivum.com/app/uploads/2024/07/7-1024x768.jpg 1024w, https://arkivum.com/app/uploads/2024/07/7-300x225.jpg 300w, https://arkivum.com/app/uploads/2024/07/7-768x576.jpg 768w, https://arkivum.com/app/uploads/2024/07/7-1536x1152.jpg 1536w, https://arkivum.com/app/uploads/2024/07/7.jpg 1920w" data-sizes="auto" data-eio-rwidth="1024" data-eio-rheight="768"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/7-1024x768.jpg" srcset="https://arkivum.com/app/uploads/2024/07/7-1024x768.jpg 1024w, https://arkivum.com/app/uploads/2024/07/7-300x225.jpg 300w, https://arkivum.com/app/uploads/2024/07/7-768x576.jpg 768w, https://arkivum.com/app/uploads/2024/07/7-1536x1152.jpg 1536w, https://arkivum.com/app/uploads/2024/07/7.jpg 1920w" sizes="(max-width: 1024px) 100vw, 1024px" height="1440" width="1920" alt="Arkivum image" class="size-full object-cover " data-eio="l"></noscript></div></div><div class="lg:order-2" data-aos="fade-in"><div class=" lg:py-60px"><h2 class="mb-5 text-2xl md:text-4xl font-extrabold text-white">Centralised digital preservation for long-term GCP compliance</h2><div class="content-wrapper mb-5 text-white content-white" ><p>Leaving data in an eTMF solution, eClinical system or even a file sharing platform such as SharePoint is not viable long-term archiving solution. These systems are not designed to maintain data integrity for decades or longer and can leave your organisation at risk of critical inspection findings.</p><p>To guarantee data endures and remains legible, sponsors must actively maintain and preserve their data throughout the entire retention period</p><p><strong>Archiving all long-term clinical records and data in a single repository enables:</strong></p><ul><li>Active digital safeguarding and preservation to maintain data integrity in line with ALCOA+ forever</li><li>Adherence to EU CTR, FDA CFR 21 Part 11 and ICH E6 R3</li><li>Easily search and access clinical records and data, supporting inspection readiness</li><li>Manage audited user access and regulatory demands</li><li>Cost-effective long-term solution which avoids vendor lock-in</li></ul><p><span style="font-weight: 400;">Find out more about the Arkivum solution <a href="https://arkivum.com/solution/">here</a></span></p></div></div></div></div></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-black wp-elements-f97262ecc5f293f1998ba26fc495c3a2"><div class="relative"><div class="absolute inset-y-0 left-0 right-[68%] hidden lg:block"><div class="absolute top-0 right-0 bg-quote-mark bg-center bg-no-repeat size-170px bg-contain z-20 translate-x-1/2"></div><div class="rounded-r-5px overflow-hidden h-full" data-aos="fade-right"><div class="swiper testimonial-thumb h-full"><div class="swiper-wrapper"><div class="swiper-slide !h-auto"><div class="h-full "><div class="absolute inset-0 bg-black/60"></div> <img decoding="async" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAABAAAAAKrAQMAAABV2G3XAAAABlBMVEUAAAD///+l2Z/dAAAAAXRSTlMAQObYZgAAAAlwSFlzAAAOxAAADsQBlSsOGwAAAGxJREFUeNrtwTEBAAAAwqD1T20MH6AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAOBtYOgAB23VbnQAAAABJRU5ErkJggg==" height="1200" width="1800" alt="Arkivum image" class="size-full object-cover lazyload" data-src="https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-1024x683.jpg" data-srcset="https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-1024x683.jpg 1024w, https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-300x200.jpg 300w, https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-768x512.jpg 768w, https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-1536x1024.jpg 1536w, https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo.jpg 1800w" data-sizes="auto" data-eio-rwidth="1024" data-eio-rheight="683"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-1024x683.jpg" srcset="https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-1024x683.jpg 1024w, https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-300x200.jpg 300w, https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-768x512.jpg 768w, https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo-1536x1024.jpg 1536w, https://arkivum.com/app/uploads/2024/07/Neuraly-Cover-Photo.jpg 1800w" sizes="(max-width: 1024px) 100vw, 1024px" height="1200" width="1800" alt="Arkivum image" class="size-full object-cover " data-eio="l"></noscript></div></div></div></div></div></div><div class="container"><div class="swiper case-studies-testimonials-swiper !overflow-visible" data-aos="fade-in"><div class="swiper-wrapper"><div class="swiper-slide py-10"><div class="ml-auto lg:w-[560px] xl:w-800px"><p class="font-bold -tracking-1% text-xl md:text-2xl mb-30px text-white"> Arkivum’s team was knowledgeable, very helpful and responsive from beginning to end. We are looking forward to working with the team for subsequent eTMF archiving needs.</p><div class="w-28 mb-2.5"> <img decoding="async" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAABAAAAACtAQMAAAAUHp/jAAAABlBMVEUAAAD///+l2Z/dAAAAAXRSTlMAQObYZgAAAAlwSFlzAAAOxAAADsQBlSsOGwAAACxJREFUeNrtwTEBAAAAwqD1T20MH6AAAAAAAAAAAAAAAAAAAAAAAAAAAADgbFctAAEmGtCOAAAAAElFTkSuQmCC" height="189" width="1117" alt="Arkivum image" class="size-full max-h-[100px] object-contain lazyload" data-src="https://arkivum.com/app/uploads/2021/04/Neuraly_2-1024x173.png" data-srcset="https://arkivum.com/app/uploads/2021/04/Neuraly_2-1024x173.png 1024w, https://arkivum.com/app/uploads/2021/04/Neuraly_2-300x51.png 300w, https://arkivum.com/app/uploads/2021/04/Neuraly_2-768x130.png 768w, https://arkivum.com/app/uploads/2021/04/Neuraly_2.png 1117w" data-sizes="auto" data-eio-rwidth="1024" data-eio-rheight="173"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2021/04/Neuraly_2-1024x173.png" srcset="https://arkivum.com/app/uploads/2021/04/Neuraly_2-1024x173.png 1024w, https://arkivum.com/app/uploads/2021/04/Neuraly_2-300x51.png 300w, https://arkivum.com/app/uploads/2021/04/Neuraly_2-768x130.png 768w, https://arkivum.com/app/uploads/2021/04/Neuraly_2.png 1117w" sizes="(max-width: 1024px) 100vw, 1024px" height="189" width="1117" alt="Arkivum image" class="size-full max-h-[100px] object-contain " data-eio="l"></noscript></div><p class=" mb-0 text-base text-white">Neuraly</p><div class="mt-10"> <a href="https://arkivum.com/case-studies/neuraly-case-study-helping-a-revolutionary-clinical-stage-biotechnology-company-become-gcp-compliant/" class="y-btn btn-white" target=""> Read case study </a></div></div></div></div></div></div></div></section><section class="relative md:h-[120px] "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-black"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-white"></div><div class="relative stream-wrapper"> <svg class="w-full h-60px md:h-120px object-cover " fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#050505"/> </svg></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-white wp-elements-7c41fd4d73a9c99a5d3d0ce77b1941d5"><div class="container"><div class="lg:text-center mb-60px" data-aos="fade-in"><h2 class="mb-5 text-2xl md:text-4xl font-extrabold text-black">GCP Archive Storage and Data Integrity</h2><div class="content-wrapper text-black" ><p>Arkivum is the only validated GCP archiving and preservation solution. Our retention system supports clinical trial sponsors, sites and CROs to ensure that their records and data are inspection-ready and retained in line with the ALCOA+ principles.</p><p>Below are some of the key features supporting life sciences organisations within clinical trials. Click on the links below to find out more.</p></div></div><div class="grid lg:grid-cols-3 gap-10 lg:gap-60px"><div data-aos="fade-in"><div class="size-60px mb-5"> <img decoding="async" src="data:image/png;base64,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" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain lazyload" data-src="https://arkivum.com/app/uploads/2024/07/Preservation.png" data-srcset="https://arkivum.com/app/uploads/2024/07/Preservation.png 1600w, https://arkivum.com/app/uploads/2024/07/Preservation-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Preservation-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Preservation-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Preservation-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Preservation-1536x1536.png 1536w" data-sizes="auto" data-eio-rwidth="1600" data-eio-rheight="1600"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/Preservation.png" srcset="https://arkivum.com/app/uploads/2024/07/Preservation.png 1600w, https://arkivum.com/app/uploads/2024/07/Preservation-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Preservation-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Preservation-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Preservation-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Preservation-1536x1536.png 1536w" sizes="(max-width: 1600px) 100vw, 1600px" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain " data-eio="l"></noscript></div><h4 class="text-xl mb-2.5 text-black">Preservation of Clinical Trial Records and Data</h4><div class="mb-0 content-wrapper text-black"><p>At Arkivum, we don’t just archive data; we preserve it. Recognising that the software and hardware of today may not be accessible in 25 years’ time, our solution remains ahead of the curve, guaranteeing that your valuable GCP data remains both legible and human-readable in the future.</p></div><div class="btn-set mt-5"> <a href="https://arkivum.com/preservation/" class="y-btn btn-black" target=""> Find out more </a></div></div><div data-aos="fade-in"><div class="size-60px mb-5"> <img decoding="async" src="data:image/png;base64,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" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain lazyload" data-src="https://arkivum.com/app/uploads/2024/07/Regulatory.png" data-srcset="https://arkivum.com/app/uploads/2024/07/Regulatory.png 1600w, https://arkivum.com/app/uploads/2024/07/Regulatory-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Regulatory-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Regulatory-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Regulatory-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Regulatory-1536x1536.png 1536w" data-sizes="auto" data-eio-rwidth="1600" data-eio-rheight="1600"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/Regulatory.png" srcset="https://arkivum.com/app/uploads/2024/07/Regulatory.png 1600w, https://arkivum.com/app/uploads/2024/07/Regulatory-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Regulatory-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Regulatory-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Regulatory-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Regulatory-1536x1536.png 1536w" sizes="(max-width: 1600px) 100vw, 1600px" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain " data-eio="l"></noscript></div><h4 class="text-xl mb-2.5 text-black">Regulatory Tools to Manage Retention Requirements</h4><div class="mb-0 content-wrapper text-black"><p>Arkivum simplifies compliance. Our solution ensures your data is always inspection-ready, featuring robust audit trails and full data encryption. Managing highly regulated long-term data does not have to be difficult, Arkivum’s validated archiving and preservation solution aligns with EU CTR, ensuring the integrity of your data for as long as you need it.</p></div><div class="btn-set mt-5"> <a href="https://arkivum.com/regulatory/" class="y-btn btn-black" target=""> Find out more </a></div></div><div data-aos="fade-in"><div class="size-60px mb-5"> <img decoding="async" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAABkAAAAZAAQMAAAAbwhzkAAAABlBMVEUAAAD///+l2Z/dAAAAAXRSTlMAQObYZgAAAAlwSFlzAAAOxAAADsQBlSsOGwAAAU5JREFUeNrtwTEBAAAAwqD1T20MH6AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAOBv6HwAATejY2YAAAAASUVORK5CYII=" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain lazyload" data-src="https://arkivum.com/app/uploads/2024/07/Migration.png" data-srcset="https://arkivum.com/app/uploads/2024/07/Migration.png 1600w, https://arkivum.com/app/uploads/2024/07/Migration-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Migration-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Migration-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Migration-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Migration-1536x1536.png 1536w" data-sizes="auto" data-eio-rwidth="1600" data-eio-rheight="1600"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/Migration.png" srcset="https://arkivum.com/app/uploads/2024/07/Migration.png 1600w, https://arkivum.com/app/uploads/2024/07/Migration-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Migration-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Migration-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Migration-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Migration-1536x1536.png 1536w" sizes="(max-width: 1600px) 100vw, 1600px" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain " data-eio="l"></noscript></div><h4 class="text-xl mb-2.5 text-black">Data Migration Service</h4><div class="mb-0 content-wrapper text-black"><p>As part of Arkivum’s fully validated migration service, we collaborate directly with CROs and sponsors to ensure seamless and effective data migration, minimising disruption to our clients. Once the data is archived, automatic data integrity checks ensure that all data is complete, providing peace of mind.</p></div><div class="btn-set mt-5"> <a href="https://arkivum.com/migration-service/" class="y-btn btn-black" target=""> Find out more </a></div></div></div></div></section><section class="relative md:h-[120px] "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-white"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-black"></div><div class="relative stream-wrapper"> <svg class="w-full h-60px md:h-120px object-cover " fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#050505"/> </svg></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-black relative wp-elements-6595d6c2dc830a1c29837611448ff21e"><div class="absolute top-1/2 inset-x-0 -translate-y-1/2"> <svg class="w-full h-60px md:h-90px object-cover -scale-y-100" fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#00D48C"/> </svg> <svg class="w-full h-60px md:h-90px object-cover -scale-y-100" fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#00D48C"/> </svg></div><div class="container"><div class="bg-grey-dark rounded-5px p-30px md:p-60px relative"><div class="lg:flex gap-10 lg:gap-20"><div data-aos="fade-in"><h2 class="text-2xl text-white">eBook: A guide to preserving essential GCP records and data</h2><div class="content-wrapper mb-5 text-white" ><p>Download our free guide on how and where to get started with your GCP data archiving and preservation. Includes compliance with key regulations and the long-term alignment to the ALCOA+ principles.</p></div><div class="btn-set "> <a href="https://arkivum.com/ebooks/new-ebook-providing-practical-guidance-on-how-to-retain-essential-gcp-records-and-data-in-line-with-ich-e6-r3-and-the-alcoa-principles/" class="y-btn btn-white" target="_blank"> Access here </a></div></div><div class="hidden lg:block" data-aos="fade-in"> <img decoding="async" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAABAAAAAMMAQMAAAD3tkc1AAAABlBMVEUAAAD///+l2Z/dAAAAAXRSTlMAQObYZgAAAAlwSFlzAAAOxAAADsQBlSsOGwAAAHdJREFUeNrtwQEBAAAAgiD/r25IQAEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAADwbokbAAHu2/GIAAAAAElFTkSuQmCC" height="1463" width="1920" alt="Arkivum image" class="size-full object-contain lazyload" data-src="https://arkivum.com/app/uploads/2024/07/Clinical-eBook-1024x780.jpg" data-srcset="https://arkivum.com/app/uploads/2024/07/Clinical-eBook-1024x780.jpg 1024w, https://arkivum.com/app/uploads/2024/07/Clinical-eBook-300x229.jpg 300w, https://arkivum.com/app/uploads/2024/07/Clinical-eBook-768x585.jpg 768w, https://arkivum.com/app/uploads/2024/07/Clinical-eBook-1536x1170.jpg 1536w, https://arkivum.com/app/uploads/2024/07/Clinical-eBook.jpg 1920w" data-sizes="auto" data-eio-rwidth="1024" data-eio-rheight="780"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/Clinical-eBook-1024x780.jpg" srcset="https://arkivum.com/app/uploads/2024/07/Clinical-eBook-1024x780.jpg 1024w, https://arkivum.com/app/uploads/2024/07/Clinical-eBook-300x229.jpg 300w, https://arkivum.com/app/uploads/2024/07/Clinical-eBook-768x585.jpg 768w, https://arkivum.com/app/uploads/2024/07/Clinical-eBook-1536x1170.jpg 1536w, https://arkivum.com/app/uploads/2024/07/Clinical-eBook.jpg 1920w" sizes="(max-width: 1024px) 100vw, 1024px" height="1463" width="1920" alt="Arkivum image" class="size-full object-contain " data-eio="l"></noscript></div></div></div></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-black wp-elements-1438c2b148f7454936752959283f24da"><div class="container"><div class="grid md:grid-cols-2 item-center gap-5 md:gap-20 xl:gap-[160px]"><div class="relative" data-aos="fade-in"><div class="h-px md:h-full w-full md:w-px bg-white opacity-20 absolute bottom-0 inset-x-0 inset-x-none md:left-auto md:inset-y-0 md:-right-10 xl:-right-20"></div><h2 class="text-white text-2xl md:text-4xl font-extrabold">Partner with Arkivum</h2></div><div data-aos="fade-in"><div class="content-wrapper mb-5 text-white" ><p><strong>Are you from a CRO, GCP consultancy or eClinical solution provider?</strong></p><p>Arkivum work with a range of partners within the clinical trial sector, supporting the application of good clinical practice. If you’re interested in collaborating with Arkivum, please explore our partner page.</p></div><div class="btn-set "> <a href="https://arkivum.com/partners/" class="y-btn btn-white" target=""> Find out more </a></div></div></div></div></section><section class="relative md:h-[120px] "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-black"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-white"></div><div class="relative stream-wrapper"> <svg class="w-full h-[60px] md:h-[120px] object-cover rotate-180 -scale-y-100" fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-66 54.2271V122H871.983C891.795 122 911.15 115.934 927.392 104.627L955.39 85.1456C971.654 73.8392 990.987 67.7729 1010.8 67.7729H1878V0H1127.71C1107.9 0 1088.55 6.0663 1072.3 17.3727L1044.31 36.8544C1028.04 48.1608 1008.71 54.2271 988.897 54.2271H-66Z" fill="#050505"/> </svg></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-white wp-elements-c9528004d04bd14cad35635bf35d1b38"><div class="container"><div class="xl:flex gap-60px"><div class="lg:w-400px mb-5 xl:mb-0 flex-shrink-0"><h2 class="text-black text-2xl md:text-4xl font-extrabold">eTMF and GCP Compliance FAQs</h2></div><div class="w-full" itemscope="" itemtype="https://schema.org/FAQPage"><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Why can’t I leave my data in an eTMF solution at the end of a study phase?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>While it is possible to leave data in an eTMF system at the end of trial, there are several reasons why Arkivum would strongly recommend migrating the data to a dedicated digital archive.</p><p>Firstly, eTMF systems are not designed to archive data for long periods of time, and do not have the capability to safeguard and preserve digital content. The longer that it is kept within the source system, the greater at risk that data is.</p><p>Secondly, the longer that data is kept within the source system, the harder and more complex the data migration process will be. As staff move onto other projects or churn, it will become the responsibility of those unfamiliar with the data to migrate it.</p><p>Finally, Arkivum typically find that it is much more cost effective for customers to move their long-term data into a centralised repository. An added benefit of taking this approach is that it avoids vendor lock in and data becoming stuck in disparate and siloed systems.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Can I archive clinical data with Arkivum?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>Yes, it is possible to archive any clinical data within the Arkivum solution. This includes (but not limited to), eCRF, eCTD, ePRO and more.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Which eTMF solution providers does your solution support?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>Arkivum is experienced at working with a range of different eTMF and eClinical solutions. Where direct integrations do not exist, we can work with you as part of the migration service to extract and prepare your data for archive, regardless of source system.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Does the Arkivum solution align to the TMF reference model?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>Yes, the Arkivum solution supports the TMF reference model. Users can use whatever structure within the archive as required, including both a standard or bespoke application of the reference model. It is possible for one customer to also adopt multiple structures for their data within the system, for example if a sponsor has multiple studies, from multiples trials, all in different structures.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Do you work directly with CROs?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>Yes, Arkivum typically works directly with CROs as part of our migration service. Depending on the arrangement, Arkivum can work directly with your CRO partners to receive end-of-study data. As part of that process, we also quality-check all records to ensure completeness and accuracy of the files and records.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">How does the Arkivum solution support inspection readiness?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>The Arkivum solution is live archive, not a locked system. This means that data can be easily accessed and searched, enabling life sciences organisations to easily make requested data available. In some instances, customers may even want to provide inspectors with a bespoke login, enabling them to review and search relevant documentation as required.</p><p>In addition to this, by maintaining all of your long-term and quality checked records and data in a single repository, customers can have peace of mind that is it both inspection prepared and inspection ready.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Does the Arkivum solution adhere to regulations such as EU CTR and the FDA CFR 21 Part 11?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>Yes, the Arkivum solution has been developed to support life sciences organisations to adhere to retention regulations and guidance. This includes EU CTR (EU Regulation 536/2014) which requires the retention of the TMF for at least 25 years, the FDA’s CFR 21 Part 11 and ICH E6 R3.</p><p>The solution has also been mapped to industry best practice guidelines such as the ALCOA++ principles, which are included with the EU’s Guidelines for Computerised Systems.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Do you only archive eTMF records?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>No, the Arkivum solution can and is used to archive a range of GxP and non-GxP data. Within the clinical arena this could include but not limited to eCRF, eCTD and ePRO datasets.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">What validation testing do you do?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>Arkivum conducts computer system validation (CSV) which includes testing and confirming that the Arkivum solution meets documented security requirements. Arkivum also conducts penetration testing on the solution.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Do you have validation documentation?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>Where required, Arkivum provides a validation pack (which includes a requirements traceability matrix, test plan, test scripts, and validation summary report), a 21 CFR Part 11 compliance assessment, a penetration testing report, and the impact assessment for GxP Data Integrity, Confidentiality, Privacy.</p></div></div></div><div class="border-b border-black/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-black icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-black">Are you certified in any ISO standards?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-black text-black pb-15px" itemprop="text"><p>Yes, Arkivum is certified in both ISO 9001(Quality Management) and ISO 27001 (Information Security). You can access our certificates here <a href="https://arkivum.com/app/uploads/2024/07/240627-ISO-9001-Certificate-Arkivum.pdf" target="_blank" rel="noopener">ISO 9001,</a> <a href="https://arkivum.com/app/uploads/2024/07/240627-ISO-27001-2022-Certificate-Arkivum.pdf" target="_blank" rel="noopener">ISO 27001</a></p></div></div></div></div></div></div></section></div><section class="relative bg-white"><div class="absolute inset-0 top-1/3 md:top-1/2 bottom-0 bg-black"></div><div class="container relative"><div class="bg-green rounded-5px py-25px md:py-10 px-15px md:px-60px md:flex gap-10 items-center justify-between" data-aos="fade-up"><div class="max-w-800px"><h2 class="text-lg md:text-2xl mb-2">Interested in finding out more?</h2><div class="content-wrapper " ><p>Message us via our contact us page or book some time in with one of our experienced team. 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