{"id":45471,"date":"2022-01-27T09:00:46","date_gmt":"2022-01-27T09:00:46","guid":{"rendered":"https:\/\/www.arisglobal.com\/?p=45471"},"modified":"2022-01-27T09:00:46","modified_gmt":"2022-01-27T09:00:46","slug":"select-automated-drug-safety-platform","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/select-automated-drug-safety-platform\/","title":{"rendered":"How to Select an Automated Drug Safety Platform in Three Steps"},"content":{"rendered":"<p><span data-contrast=\"auto\">Your team\u2019s workload grows by the day. The\u00a0volume\u00a0of\u00a0Safety cases you\u2019re managing\u00a0increases\u00a0significantly\u00a0every year. All the same, the internal pressure to save the organization time and money is mounting.\u00a0Automation\u00a0has never been more pivotal to the success of Safety teams like yours.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">It\u2019s not\u00a0enough to have a dedicated\u00a0<a href=\"https:\/\/lifesphere.arisglobal.com\/platform\/safety\/\">drug\u00a0safety\u00a0solution<\/a>.\u00a0The\u00a0<\/span><a href=\"https:\/\/www.idc.com\/getdoc.jsp?containerId=US45863116\"><span data-contrast=\"none\">IDC estimates<\/span><\/a><span data-contrast=\"auto\">\u00a0case volumes are growing 30-50% each year,\u00a0driven by multiple factors, including the rise of new digital reporting channels and more treatments for complex diseases.\u00a0In response to this pressure,\u00a0more and more organizations are turning to automation to\u00a0manage\u00a0growing\u00a0case volumes\u00a0while driving\u00a0operational and financial efficiency.\u00a0Automation provides the path\u00a0forward.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The benefits of automation go beyond increased efficiency,\u00a0providing additional benefits like increased data quality, greater process consistency, and the\u00a0opportunity to shift resources toward higher value initiatives.\u00a0From robotic\u00a0process automation (RPA)\u00a0to\u00a0artificial intelligence (AI)\u00a0and\u00a0machine learning (ML), automation eliminates\u00a0repetitive tasks from employees\u2019\u00a0workloads\u00a0and\u00a0empowers employees to make better\u00a0<\/span><a href=\"https:\/\/arisglobal.drift.click\/bccbdbea-c579-4392-bbdc-774d5ddb43ad\"><span data-contrast=\"none\">decisions faster via AI-powered insights<\/span><\/a><span data-contrast=\"auto\">. Automation provides organizations with the potential to transform Safety from a\u00a0cost center to a strategic pillar of innovation.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">If you\u2019re looking to\u00a0upgrade your <a href=\"https:\/\/lifesphere.arisglobal.com\/platform\/safety\/\">Safety system<\/a> to one with robust automation capabilities, you\u2019re not alone:\u00a0leading\u00a0biopharmas\u00a0are aggressively investing in\u00a0case management\u00a0automation, and\u00a0<\/span><a href=\"https:\/\/www.arisglobal.com\/industry-report-2021\/\"><span data-contrast=\"none\">74% of organizations across the life sciences industry<\/span><\/a><span data-contrast=\"auto\">\u00a0say\u00a0that the opportunity to have automated safety signal detection and risk management would be beneficial or even\u00a0game-changing.\u00a0Even the\u00a0<\/span><a href=\"https:\/\/www.arisglobal.com\/press-release\/the-fda-goes-live-with-lifesphere-multivigilance-modernizing-pharmacovigilance-capabilities-with-faers-ii\/\"><span data-contrast=\"none\">world\u2019s biggest regulators<\/span><\/a><span data-contrast=\"auto\">\u00a0are adopting automation technology.\u00a0As you evaluate\u00a0automated <a href=\"https:\/\/lifesphere.arisglobal.com\/platform\/safety\/\">Safety\u00a0solutions<\/a>, here are three major\u00a0elements\u00a0you should\u00a0consider.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload wp-image-45475 aligncenter size-large\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271024%27%20height%3D%27557%27%20viewBox%3D%270%200%201024%20557%27%3E%3Crect%20width%3D%271024%27%20height%3D%27557%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/www.arisglobal.com-content\/uploads\/2022\/01\/Generic-Lab-1024x557.png\" alt=\"People in hazmat suits work in a lab.\" width=\"1024\" height=\"557\" \/><\/p>\n<h2><b><span data-contrast=\"auto\">1. <\/span><\/b><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span>Focus on a <a href=\"https:\/\/lifesphere.arisglobal.com\/platform\/safety\/\">drug safety platform provider<\/a> who is an expert in both drug safety and technology<\/h2>\n<p><span data-contrast=\"auto\">Some companies\u00a0are\u00a0experts\u00a0in life sciences and\u00a0understand\u00a0drug\u00a0safety\u00a0operations inside and out. Others are technology\u00a0experts, nimbly crafting and training\u00a0best-in-class\u00a0intelligent\u00a0automation.\u00a0However,\u00a0very few\u00a0are both.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Safety operations and case management\u00a0is\u00a0highly specialized. The\u00a0entire system must be carefully built to manage the\u00a0distinct\u00a0needs of\u00a0a Safety team, and the automation\u00a0embedded into\u00a0best practice\u00a0workflows for\u00a0compliant\u00a0case management. In some\u00a0instances,\u00a0a software provider may\u00a0start with\u00a0an\u00a0established\u00a0Safety solution\u00a0and\u00a0later add\u00a0automation\u00a0capabilities, but\u00a0fail to integrate the two. If the automation functionality is not built\u00a0within the\u00a0platform but\u00a0rather\u00a0tacked on as a feature,\u00a0the\u00a0\u201csolution\u201d becomes\u00a0cumbersome\u00a0and\u00a0ill-equipped to handle industry-specific processes,\u00a0potentially requiring\u00a0a human touch to move from process to process.\u00a0Teams without end-to-end automation miss out on the additional gains that come from automating tasks that are deeper within the case management workflows.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The ideal\u00a0<a href=\"https:\/\/lifesphere.arisglobal.com\/platform\/safety\/\">Safety\u00a0technology<\/a> vendor is one\u00a0with\u00a0a wealth of\u00a0safety\u00a0industry experience and a track record of\u00a0expertise and in-house\u00a0investment in automation technology.\u00a0Both are critical\u00a0to\u00a0building a\u00a0reliably automated Safety system.\u00a0Companies without Safety experience lack\u00a0an\u00a0intimate understanding of complex\u00a0and nuanced Safety workflows\u00a0\u2013 something these vendors may underestimate or rely on your organization to train them on.\u00a0At the same time,\u00a0you\u2019ll want to seek out in-house automation expertise, because it\u2019s required to identify the right tasks to automate,\u00a0to choose\u00a0the technology best suited to handle those tasks, and to deliver that automation seamlessly in a Safety solution.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Here are a few signs that the technology vendor you\u2019re investigating is industry-trusted with reliable automation capabilities:\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Drug Safety and pharmacovigilance expertise<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">In-house <a href=\"https:\/\/lifesphere.arisglobal.com\/automation-pharmacovigilance\/\">automation<\/a> expertise<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Robust and ongoing investment in automation technology\u00a0<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Natively integrated approach to <a href=\"https:\/\/lifesphere.arisglobal.com\/automation-pharmacovigilance\/\">Safety automation<\/a><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">Roster of customers using automation in-production, including CROs, sponsors, and regulatory bodies alike<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<h2><b><span data-contrast=\"auto\">2. \u202f<\/span><\/b><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span>While <a href=\"https:\/\/lifesphere.arisglobal.com\/automation-pharmacovigilance\/\">automation in drug safety<\/a> is a huge efficiency win, ensure the automation capabilities are transparent and pre-validated by Drug Safety Experts<\/h2>\n<p><span data-contrast=\"auto\">Safety is too\u202fimportant\u202fto trust\u00a0unexplained\u00a0functionality. The Safety solution you choose should\u202fallow your organization to\u00a0understand, and\u00a0explain to an auditor,\u202fwhat steps the automated system performed and why. This means the system\u202fis transparent\u202fand\u00a0validate-able, not a mysterious \u201cblack box\u201d\u00a0the vendor\u00a0asks you to trust.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The best\u00a0Safety solutions will come with intelligent automation that has been\u00a0pre-trained with an incredibly extensive set of\u00a0data\u00a0and\u00a0rigorous training exercises modeled after what is encountered in real-life environments.\u00a0Access to this data in quantities large enough to successfully\u00a0train these\u00a0systems will only be available to technology vendors with a long, rich history in the\u00a0Safety\u00a0industry.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">With access to enormous data sets like these, it\u2019s possible to pre-validate an automated Safety system.\u00a0In this case, pre-validated means\u00a0the intelligent\u00a0system has processed\u00a0and learned from\u00a0enough\u00a0data that it is\u00a0ready\u00a0for\u00a0near\u00a0immediate,\u00a0out-of-the-box\u00a0use\u00a0by any organization following\u00a0standard,\u00a0compliant procedures.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Conversely,\u00a0some\u00a0vendors\u00a0work on the refuted assumption that every automation deployment requires a from-scratch validation exercise. These vendors impose expensive consulting\u00a0engagements\u00a0for training and validation during implementation.\u00a0This consultant is essentially in place to quality check the automated system, incurring additional, ongoing costs.\u00a0These systems are always reliant on the consultant and lock organizations into\u00a0expensive\u00a0third-party agreements.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload wp-image-45476 aligncenter size-large\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271024%27%20height%3D%27557%27%20viewBox%3D%270%200%201024%20557%27%3E%3Crect%20width%3D%271024%27%20height%3D%27557%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/www.arisglobal.com-content\/uploads\/2022\/01\/Generic-\u0393Co-33-1024x557.png\" alt=\"A close-up image of a laptop with graphical data on the screen\" width=\"1024\" height=\"557\" \/><\/p>\n<p><span data-contrast=\"auto\">On the other\u00a0hand,\u00a0some software vendors may claim their solutions have been validated while emphasizing a need to train the automation using a customer\u2019s bespoke data \u2013 another avoidable cost.\u00a0These systems work, but they must be calibrated to each individual organization\u2019s datasets and workflows. This significantly elongates the\u00a0implementation process, costing the organization valuable time and resources.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The ideal Safety solutions\u00a0offer pre-validation, meaning the automation technology is\u00a0intelligent and reliable enough to produce accurate and trustworthy results for any life science organization, immediately upon implementation.\u00a0As previously stated, these systems undergo AI\/ML\u00a0model training during\u00a0development,\u00a0before\u00a0the automation\u00a0ever hits the market,\u00a0saving time and money on behalf of\u00a0the\u00a0customer.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">This is why\u202fit\u2019s critical to choose the right\u202findustry-trusted\u202ftechnology partner.\u00a0In order to develop a\u202fsolution that is\u202fintelligent and sophisticated enough to be pre-validated, that vendor needs access to an enormous repository of historical Safety data. The more data points\u202fartificial\u202fintelligence\u202flearns\u00a0from, the better trained\u00a0and\u00a0more reliable it will be in practice.\u202fThis is the same reason you\u00a0should\u00a0seek a solution that was developed with input from the\u00a0life sciences\u00a0industry.\u202fWithout Safety expertise, a technology vendor cannot\u00a0train its AI to handle Safety cases appropriately, with industry-standard practices and compliance.\u00a0Technology providers with\u00a0the\u00a0most field deployments,\u00a0real data,\u00a0and\u00a0proven experience\u00a0are best equipped to identify the functions ripe for automation<\/span><span data-contrast=\"auto\">,<\/span><span data-contrast=\"auto\">\u00a0the right\u00a0automation tool to apply for best results.\u00a0\u202f<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2><b><span data-contrast=\"auto\">3. <\/span><\/b><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span>Choose an end-to-end solution for Drug Safety Monitoring automation<\/h2>\n<p><span data-contrast=\"auto\">Many\u202fexisting solutions\u202fpromise full-scope\u202fautomation but\u202fdeliver only\u00a0on the ability to automate\u00a0select\u00a0tasks\u00a0like data\u00a0intake.\u00a0While\u00a0these\u00a0worthwhile use\u00a0cases\u00a0can\u00a0save time and effort, it\u2019s only the tip of the automation iceberg.\u202f\u202f<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For optimal return on investment\u00a0and true efficiency gains,\u00a0seek\u00a0a solution that\u202fhas mature, end-to-end\u00a0automation capabilities.\u00a0These\u00a0platforms apply <a href=\"https:\/\/lifesphere.arisglobal.com\/automation-pharmacovigilance\/\">automation\u00a0<\/a>deep within Safety workflows,\u00a0rather than only to\u00a0a\u00a0few peripheral\u00a0tasks\u00a0to the overall\u00a0case management.\u00a0An end-to-end approach\u00a0enables Safety teams to\u00a0allow the system to automatically\u00a0run\u00a0integrated\u00a0workflows,\u00a0greatly accelerating\u00a0case processing speed.\u00a0End-to-end automation\u00a0can even\u00a0enable\u00a0functionality like touchless case processing of non-severe adverse events, allowing employees to oversee the process, but focus much of their time and attention\u00a0on\u00a0nuanced aspects of Safety that benefit from or require human judgment.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">When Safety systems are equipped with <a href=\"https:\/\/lifesphere.arisglobal.com\/automation-pharmacovigilance\/\">end-to-end automation<\/a>,\u00a0full\u00a0efficiency gains are realized. The automation goes beyond\u00a0deterministic\u00a0functionality and disconnected\u00a0automation tools\u00a0to\u00a0alleviate employees\u2019 workload and free their time for strategic, complex problem-solving.\u00a0By choosing a solution that automates workflows across the Safety spectrum, from\u00a0intake to submission\u00a0and on to\u00a0signal detection and risk management, you\u2019ll be arming your organization with\u00a0a powerful tool that\u00a0provides efficiency beyond the sum of the time saved from automating individual tasks.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2>How to Take Your Drug Safety Operations to the Next Level with Drug Safety Automation Solutions<\/h2>\n<p><span data-contrast=\"auto\">While it\u2019s clear that automation is the way forward for Safety teams, choosing the right system can be daunting.\u00a0Many technology vendors promise best-of-breed functionality but\u00a0miss the mark\u00a0when it comes to true capability.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Organizations looking to invest in a next-generation Safety system should seek a technology vendor with\u00a0proven industry knowledge that can deliver a pre-validated solution with true end-to-end automation. These are the more important factors to evaluate when vetting potential Safety solutions\u2019 automation\u00a0capabilities.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.arisglobal.com\/demo-request\/\"><span data-contrast=\"none\">Talk to us<\/span><\/a><span data-contrast=\"auto\">\u00a0to learn more about how automation can\u00a0benefit your Safety team.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><img decoding=\"async\" class=\"lazyload wp-image-45474 aligncenter size-large\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271024%27%20height%3D%27536%27%20viewBox%3D%270%200%201024%20536%27%3E%3Crect%20width%3D%271024%27%20height%3D%27536%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/www.arisglobal.com-content\/uploads\/2022\/01\/beakers-1024x536.png\" alt=\"Beakers sit on a lab bench\" width=\"1024\" height=\"536\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Your team\u2019s workload grows by the day. The\u00a0volume\u00a0of\u00a0Safety cases you\u2019re [&hellip;]<\/p>\n","protected":false},"author":27,"featured_media":48206,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[],"class_list":["post-45471","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.4 (Yoast SEO v23.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How to Select an Automated Drug Safety Platform | ArisGlobal<\/title>\n<meta name=\"description\" content=\"Consider these three major elements before deciding on an automated drug Safety platform to ensure optimal efficiency gains and return on investment.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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