{"id":4921,"date":"2021-03-12T13:58:15","date_gmt":"2021-03-12T12:58:15","guid":{"rendered":"https:\/\/q-finity.de\/company\/referenzen\/investigator-notification-system-implementation\/"},"modified":"2024-04-03T13:17:58","modified_gmt":"2024-04-03T11:17:58","slug":"investigator-notification-system-implementation","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/investigator-notification-system-implementation\/","title":{"rendered":"Investigator Notification System Implementation"},"content":{"rendered":"<section class=\"av_textblock_section av-av_textblock-9ee6daaf882f31bf75966532cda9493c \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><\/div><\/section>\n<!-- close content main div -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" 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d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4921\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km6abike-790d96df0aca72904a1b631bbff93f12\">\n#top .av-special-heading.av-km6abike-790d96df0aca72904a1b631bbff93f12{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-km6abike-790d96df0aca72904a1b631bbff93f12 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-km6abike-790d96df0aca72904a1b631bbff93f12 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-km6abike-790d96df0aca72904a1b631bbff93f12 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-km6abike-790d96df0aca72904a1b631bbff93f12 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-km6abike-790d96df0aca72904a1b631bbff93f12 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-km6abike-790d96df0aca72904a1b631bbff93f12 av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-2  avia-builder-el-no-sibling  shadoworange av-inherit-size\"><h1 class=\"av-special-heading-tag \" itemprop=\"headline\">Investigator Notification System Implementation &ndash; Case Study<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id=\"after_section_1\" class=\"main_color av_default_container_wrap container_wrap fullsize\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4921\"><div class=\"entry-content-wrapper clearfix\">\n<section class=\"av_textblock_section av-av_textblock-9ee6daaf882f31bf75966532cda9493c \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><\/div><\/section>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mc27sk-73a78f803614f2eccff97d717eb23039\">\n.avia-section.av-mc27sk-73a78f803614f2eccff97d717eb23039 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-mc27sk-73a78f803614f2eccff97d717eb23039 .scroll-down-link{\ncolor:#ea5b0c;\n}\n#top .avia-section.av-mc27sk-73a78f803614f2eccff97d717eb23039 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section<\/title>\n<desc id=\"av-svg-desc-2\">Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4921\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-l3bpec-e2acebc4e129e9864747e34e8ea9f957 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3bpec-e2acebc4e129e9864747e34e8ea9f957\">\n.flex_column.av-l3bpec-e2acebc4e129e9864747e34e8ea9f957{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\n}\n<\/style>\n<div class=\"flex_column av-l3bpec-e2acebc4e129e9864747e34e8ea9f957 av_one_half  avia-builder-el-5  el_before_av_one_half  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.av-special-heading.av-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3 av-special-heading-h2 blockquote modern-quote  avia-builder-el-6  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Problem<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-km6af419-87790699b19893b3a17703ef633af32e \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>This page deals with a case study on the topic of Investigator Notification System Implementation for conducting clinical trials.<\/p>\n<p>The customer is an international CRO for pharmaceutical companies. The services include the design and implementation of clinical studies, including all required processing of (serious) adverse events from clinical studies. Daily activities included manually notifying investigators about safety-related issues such as SUSARs. This manual <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a> was resource-intensive and error-prone. There was no solution on the market that met the customer&rsquo;s requirements, so a bespoke solution was necessary. In the project, which was continuously supported by <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a> employees, the customer wanted:<\/p>\n<ul>\n<li>Development of robust and compliant processes to electronically distribute safety information to investigators.<\/li>\n<li>Enable <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a> control through metrics and reports<\/li>\n<li>Establishing an electronic signature for important <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a> steps, e.g. acknowledgment of receipt of information by investigators<\/li>\n<li>Integratation of the solution into the customer&rsquo;s CTMS system<\/li>\n<li>Validation of the system according to the risk-based approach of GAMP 5, taking into account the new processes, integrations and functionalities, in order to meet the international regulatory requirements<\/li>\n<\/ul>\n<\/div><\/section><\/div><div class=\"av-flex-placeholder\"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1vd2zo-4a03df82401661f168bc3455f0b43eea\">\n.flex_column.av-1vd2zo-4a03df82401661f168bc3455f0b43eea{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-1vd2zo-4a03df82401661f168bc3455f0b43eea av_one_half  avia-builder-el-8  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km6admo0-25640bd85cdd74b8de191f10cb044a2a\">\n.avia-image-container.av-km6admo0-25640bd85cdd74b8de191f10cb044a2a img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-km6admo0-25640bd85cdd74b8de191f10cb044a2a .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-km6admo0-25640bd85cdd74b8de191f10cb044a2a av-styling- avia-align-center  avia-builder-el-9  avia-builder-el-no-sibling \" itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\"><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img data-opt-id=1644453301  decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-5430 avia-img-lazy-loading-not-5430 avia_image \" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:226\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/signet_PAN_orange.png\" alt=\"Q-Finity Icon\" title=\"Q-Finity Icon\" height=\"226\" width=\"300\" itemprop=\"thumbnailUrl\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:226\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/signet_PAN_orange.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1030\/h:777\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/signet_PAN_orange.png 1030w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:579\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/signet_PAN_orange.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1432\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/signet_PAN_orange.png 1536w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1431\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/signet_PAN_orange.png 2048w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1432\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/signet_PAN_orange.png 1500w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:705\/h:532\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/signet_PAN_orange.png 705w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. 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class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4921\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-f5bg04-4c55d75c6e41ff608f9116814d19f7a1 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-f5bg04-4c55d75c6e41ff608f9116814d19f7a1\">\n.flex_column.av-f5bg04-4c55d75c6e41ff608f9116814d19f7a1{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-f5bg04-4c55d75c6e41ff608f9116814d19f7a1 av_one_half  avia-builder-el-11  el_before_av_one_half  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  \"><\/div><div class=\"av-flex-placeholder\"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1fjlg4-b4c654a793cb903a830729e08d3da27e\">\n.flex_column.av-1fjlg4-b4c654a793cb903a830729e08d3da27e{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\nbackground-color:rgba(234,91,12,0.5);\n}\n<\/style>\n<div class=\"flex_column av-1fjlg4-b4c654a793cb903a830729e08d3da27e av_one_half  avia-builder-el-12  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d\">\n#top .av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d av-special-heading-h2 blockquote modern-quote  avia-builder-el-13  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Project execution<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-bx6f10-b983e9f68ba0d5403056679ace349870 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>First, new <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> entry and distribution processes had to be developed that took into account pharmacovigilance and clinical trial compliance and customer expectations. Detailed requirements had to be drawn up from these processes in order to enable the system development with an external partner. During these phases and the subsequent implementation project, the <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a> employees supported the following areas:<\/p>\n<ul>\n<li>Supplier evaluation (<a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.\" class=\"encyclopedia\">audit<\/a>) to evaluate the QMS of the system development partner.<\/li>\n<li>Review and revise the new processes to ensure that they meet international regulatory requirements, including but not limited to ICH E6 R2, pharmacovigilance regulations, ER \/ ES regulations such as 21 CRF Part 11 and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> protection regulations such as GDPR.<\/li>\n<li>Risk assessment of the processes and the supporting system to enable a lean validation approach<\/li>\n<li>Design of integrations to reduce processing times, reduce manual reconciliation activities and increase <a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a><\/li>\n<li>Planning, execution and summary of the system validation including:\n<ul>\n<li>Requirements acquisition taking into account business, regulatory, <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> protection and IT aspects<\/li>\n<li>Risk assessment and development of the validation strategy in cooperation with all partners<\/li>\n<li>Validation planning including the scaling of activities based on the risk assessment<\/li>\n<li>Installation qualification in close cooperation with the IT department of the CRO<\/li>\n<li>Configuration review as part of operational qualification<\/li>\n<li>Design and creation of the user acceptance test<\/li>\n<li>Validation of the system integrations developed by the customer<\/li>\n<li>Design and validation of reports and metrics within the CRO&rsquo;s business intelligence platform<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-90b4j8-e7507ec90d65299aa8b580a8a1904797\">\n.avia-section.av-90b4j8-e7507ec90d65299aa8b580a8a1904797 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-90b4j8-e7507ec90d65299aa8b580a8a1904797 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-90b4j8-e7507ec90d65299aa8b580a8a1904797 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_4\" class=\"avia-section av-90b4j8-e7507ec90d65299aa8b580a8a1904797 main_color avia-section-default avia-no-border-styling  avia-builder-el-15  el_after_av_section  el_before_av_postcontent  avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize\"><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><a href=\"#next-section\" title=\"\" class=\"scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello\" data-av_svg_icon=\"down-open-mini\" data-av_iconset=\"svg_entypo-fontello\"><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewbox=\"0 0 15 32\" preserveaspectratio=\"xMidYMid meet\" aria-labelledby=\"av-svg-title-4\" aria-describedby=\"av-svg-desc-4\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-4\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-4\">Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4921\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-87oe1w-3ecc571bef3e50ec0837e4121fda1ed5\">\n.flex_column.av-87oe1w-3ecc571bef3e50ec0837e4121fda1ed5{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-87oe1w-3ecc571bef3e50ec0837e4121fda1ed5 av_one_half  avia-builder-el-16  el_before_av_one_half  avia-builder-el-first  first flex_column_div av-zero-column-padding  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km6apft7-9dbbd08d0ad163ccee8a470965c13504\">\n#top .av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 av-special-heading-h2 blockquote modern-quote  avia-builder-el-17  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Result and benefit<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-km6ajolx-c6954336411199020f2999679bbeff0f \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>The project was successfully completed and the validation activities were appropriately scaled taking into account the results of the risk assessment. The excellent communication between the customer, the external development partner and the validation team was an important success factor. It enabled a holistic validation approach from the business <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a> to the user requirements to the development specifications. The entire approach and all activities could be designed from the development test to the user acceptance test, thus demonstrating the desired <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a> support and the suitability of the system for the intended use.<\/p>\n<p>The solution provided detailed compliance <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> and metrics so the company can demonstrably meet the compliance expectations of its customers and regulators.<\/p>\n<p>As the solution was &ldquo;the first of its kind&rdquo; in the industry, the approach, system and validation documentation were thoroughly examined without any major problems being found.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6lb9mc-a7a669272479fd5f4676da8b5121530a\">\n.flex_column.av-6lb9mc-a7a669272479fd5f4676da8b5121530a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-6lb9mc-a7a669272479fd5f4676da8b5121530a av_one_half  avia-builder-el-19  el_after_av_one_half  el_before_av_textblock  flex_column_div av-zero-column-padding  \"><\/div><section class=\"av_textblock_section av-lr7moldn-fa75339c3cd64291b0cf54a4a8b48ec0 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>Do you also need help with the implementation of Investigator Notification System? Then contact us <a href=\"https:\/\/q-finity.de\/en\/contact\/?swcfpc=1\">here<\/a> now! We look forward to hearing from you.<\/p>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-45u9f8-f727a45618f9258d51c199fd4c5ce4f4\">\n#top .hr.hr-invisible.av-45u9f8-f727a45618f9258d51c199fd4c5ce4f4{\nheight:100px;\n}\n<\/style>\n<div class=\"hr av-45u9f8-f727a45618f9258d51c199fd4c5ce4f4 hr-invisible  avia-builder-el-21  el_after_av_textblock  avia-builder-el-last \"><span class=\"hr-inner \"><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n\n<\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":5479,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-4921","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Investigator Notification System Implementation with QFINITY<\/title>\n<meta name=\"description\" content=\"QFINITY helps to ensure the safety of clinical trials with support by the Investigator Notification System Implementation.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/investigator-notification-system-implementation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Investigator Notification System Implementation\" \/>\n<meta property=\"og:description\" content=\"QFINITY helps to ensure the safety of clinical trials with support by the Investigator Notification System Implementation.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/investigator-notification-system-implementation\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-03T11:17:58+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/investigator-notification-system-implementation\/\",\"url\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/investigator-notification-system-implementation\/\",\"name\":\"Investigator Notification System Implementation with QFINITY\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/#website\"},\"datePublished\":\"2021-03-12T12:58:15+00:00\",\"dateModified\":\"2024-04-03T11:17:58+00:00\",\"description\":\"QFINITY helps to ensure the safety of clinical trials with support by the Investigator Notification System Implementation.\",\"breadcrumb\":{\"@id\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/investigator-notification-system-implementation\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/investigator-notification-system-implementation\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/investigator-notification-system-implementation\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\/\/q-finity.de\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Company\",\"item\":\"https:\/\/q-finity.de\/en\/company\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"References\",\"item\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Case Studies\",\"item\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/\"},{\"@type\":\"ListItem\",\"position\":5,\"name\":\"Investigator Notification System Implementation\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/q-finity.de\/en\/#website\",\"url\":\"https:\/\/q-finity.de\/en\/\",\"name\":\"QFINITY\",\"description\":\"Qualit\u00e4tsmanagement &amp; 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