{"id":36,"date":"2020-01-22T10:05:56","date_gmt":"2020-01-22T10:05:56","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=36"},"modified":"2023-05-18T12:16:41","modified_gmt":"2023-05-18T11:16:41","slug":"software","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/software\/","title":{"rendered":"Software"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\" id=\"h-software-experience-technologies\">Software experience &amp; technologies <\/h3>\n\n\n\n<p><strong>Almac Diagnostic Services has been delivering custom software solutions for Biopharma clients for many years.<\/strong> The biomarker software team is co-located in the UK and USA.<\/p>\n\n\n\n<p>Our software solutions focus around automation of data processing, filtering targets of interest, quality control assessments, assessing analytical run validity and facilitating patient test reporting outputs. We work closely with clients to identify and refine key requirements at an early stage and tailor our solutions to meet their exact needs, whether this is biomarker software for <a href=\"\/diagnostics\/clinical-trial-assays\/\">CTA (Clinical Trial Assays &#8211; either RUO or IUO)<\/a>, or <a href=\"\/diagnostics\/companion-diagnostics\/\">CDx (Companion Diagnostics)<\/a> whilst adhering to appropriate regulatory standards.<\/p>\n\n\n\n<p>We have extensive experience in developing software reporting solutions for quantitative gene expression assays using technologies such as qPCR, nanoString, RNAseq and qualitative DNA assays based on NGS. We also have demonstrable experience in developing reporting software that integrates with upstream analysis pipelines hosted on cloud-based servers.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-adherence\">Regulatory adherence <\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Certified compliance with <strong>IEC 62304 Medical Device Software: Software life-cycle processes<\/strong><\/li>\n\n\n\n<li>Certified compliance with <strong>ISO 14971 Risk management for medical devices<\/strong><\/li>\n\n\n\n<li>Experience developing software solutions compliant with <strong>21 CFR Part 11 regulations<\/strong><\/li>\n\n\n\n<li>Experience in developing software solutions as part of a medical device for regulatory submission e.g. <strong>CE marking, FDA approval<\/strong><\/li>\n\n\n\n<li>Software solutions developed are validated adhering to <strong>Almac Diagnostic Services <\/strong><strong>validation procedures<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Software Certifications:<\/strong><\/p>\n\n\n\n<div class=\"u-flex u-flex-wrap\">\n<a href=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Certificate-of-registration-1.jpg\"><img decoding=\"async\" class=\"alignnone wp-image-61571 lazyload\" data-src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Certificate-of-registration-1.jpg\" alt=\"\" width=\"237\" height=\"311\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 237px; --smush-placeholder-aspect-ratio: 237\/311;\"><noscript><img decoding=\"async\" class=\"alignnone wp-image-61571\" src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Certificate-of-registration-1.jpg\" alt=\"\" width=\"237\" height=\"311\"><\/noscript><\/a>&nbsp;&nbsp;&nbsp;<a href=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Certificate-of-registration-2.jpg\"><img decoding=\"async\" class=\"alignnone wp-image-61571 lazyload\" data-src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Certificate-of-registration-2.jpg\" alt=\"\" width=\"238\" height=\"306\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 238px; --smush-placeholder-aspect-ratio: 238\/306;\"><noscript><img decoding=\"async\" class=\"alignnone wp-image-61571\" src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Certificate-of-registration-2.jpg\" alt=\"\" width=\"238\" height=\"306\"><\/noscript><\/a>\n<\/div>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-workflow-processes\">Workflow &amp; processes <\/h3>\n\n\n\n<p>Our biomarker software development team have a comprehensive catalogue of in-house <strong>Standard Operating Procedures (SOPs)<\/strong> which are certified to <strong>comply with<\/strong> <strong>IEC 62304.<\/strong><\/p>\n\n\n\n<p>Almac adopts a phased approach to software development and conducts <strong>regular design reviews with clients at key stages<\/strong> throughout software development lifecycle.<\/p>\n\n\n\n<p><strong>Almac software process workflow:<\/strong><\/p>\n\n\n\n<p>Customised software development \u2013 Processes compliant with IEC62304.&nbsp;&nbsp;<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"824\" height=\"567\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4.jpg\" alt=\"\" class=\"wp-image-813 lazyload\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4.jpg 824w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4-300x206.jpg 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4-768x528.jpg 768w\" data-sizes=\"(max-width: 824px) 100vw, 824px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 824px; --smush-placeholder-aspect-ratio: 824\/567;\" \/><noscript><img decoding=\"async\" width=\"824\" height=\"567\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4.jpg\" alt=\"\" class=\"wp-image-813\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4.jpg 824w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4-300x206.jpg 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4-768x528.jpg 768w\" sizes=\"(max-width: 824px) 100vw, 824px\" \/><\/noscript><\/figure>\n\n\n\n<div class=\"u-flex u-block@m\">\n<div class=\"u-align-center u-p-a2 u-bg-light-grey u-m-r1 u-m-b1\" style=\"max-width: 400px;\">\n<h3>Find out more. Download the case study:<\/h3>\n<p>Almac Diagnostic Services partnered with PredictImmune to develop and validate the gene expression software algorithm used to interpret the results from the world\u2019s first validated and CE-marked prognostic test for Inflammatory Bowel Disease (IBD).<\/p>\n<p>PredictImmune selected Almac as their preferred provider for bioinformatics, software design &amp; development solutions to support the successful commercialisation and launch of the PredictSURE IBD\u2122 test.<\/p>\n<a class=\"c-btn c-btn2 u-m-t2 u-p-l1 u-p-r1\" title=\"Download\" href=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Almac-Diagnostics-Services-PredictImmune-Case-Study-WEB.pdf\">Click here to download<\/a><\/div>\n\n<div class=\"u-align-center u-p-a2 u-bg-light-grey u-m-r1 u-m-b1\" style=\"max-width: 400px;\">\n<p><a href=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Almac-Diagnostics-Services-PredictImmune-Case-Study-WEB.pdf\"><img decoding=\"async\" class=\"aligncenter wp-image-51373 size-full lazyload\" data-src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Bioinformatics-Case-study.png\" alt=\"\" width=\"300\" height=\"411\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 300px; --smush-placeholder-aspect-ratio: 300\/411;\"><noscript><img decoding=\"async\" class=\"aligncenter wp-image-51373 size-full\" src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/Bioinformatics-Case-study.png\" alt=\"\" width=\"300\" height=\"411\"><\/noscript><\/a><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Software experience &amp; technologies Almac Diagnostic Services has been delivering custom software solutions for Biopharma clients for many years. The biomarker software team is co-located in the UK and USA. Our software solutions focus around automation of data processing, filtering targets of interest, quality control assessments, assessing analytical run validity and facilitating patient test reporting [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":30,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-36","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Software - Diagnostic Services<\/title>\n<meta name=\"description\" content=\"Our software solutions focus around automation of data processing, filtering targets of interest, quality control assessments, assessing analytical run validity and facilitating patient test reporting outputs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/software\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Software\" \/>\n<meta property=\"og:description\" content=\"Our software solutions focus around automation of data processing, filtering targets of interest, quality control assessments, assessing analytical run validity and facilitating patient test reporting outputs.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/software\/\" \/>\n<meta property=\"og:site_name\" content=\"Diagnostic Services\" \/>\n<meta property=\"article:modified_time\" content=\"2023-05-18T11:16:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/4.jpg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/software\/\",\"url\":\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/software\/\",\"name\":\"Software - 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