{"id":325,"date":"2022-08-24T12:12:28","date_gmt":"2022-08-24T10:12:28","guid":{"rendered":"https:\/\/biglinksa.com\/digidata\/?page_id=325"},"modified":"2022-09-08T08:46:39","modified_gmt":"2022-09-08T06:46:39","slug":"trials","status":"publish","type":"page","link":"https:\/\/biglinksa.com\/digidata\/trials\/","title":{"rendered":"Clinical Trials"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1185.6px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:31px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-separator fusion-has-icon\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-bottom:10px;width:100%;max-width:40%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:40px;--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">The DigiData Clinical Trial Management System provides a multi-modular solution to the process of Clinical Trial Management<\/h2><\/div><ul style=\"--awb-iconcolor:var(--awb-color5);--awb-textcolor:var(--awb-color8);--awb-line-height:30.6px;--awb-icon-width:30.6px;--awb-icon-height:30.6px;--awb-icon-margin:12.6px;--awb-content-margin:43.2px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Electronic data collection into a structured database<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Standardisation of data selection and data entry that improves the accuracy and quality of the data collected<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Participant attendance monitoring and follow up initiation<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Document image collection and storage of trial related documents in one common system<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Workflow functionality that manages the completion of processes and tasks because of data collection. E.g., Clinical staff may collect data that is then routed to the PI\/SI for review.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Communication functionality that automates the sending of SMS messages to trial participants or internally within the organisation.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>A Realtime designed reporting Dashboard that allows immediate access to all data in the system at Trial, Site and Participant level for performance reporting, information access and analysis. The dashboard provides views of all data in the system and an additional \u2018download\u2019 capability where any data can be further downloaded directly from the Dashboard screens into Excel and then re-fashioned by the end user for further analysis or reporting.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Access and permission control that ensures that access to information and system function is suitably restricted.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-star fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Auditability is a key requirement for clinical trials and the system stamps every transaction with the user ID and date and time stamp of the originator.<\/p>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1185.6px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_2 1_2 fusion-flex-column fusion-flex-align-self-center\" style=\"--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:31px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">The DigiData Clinical Trial Management System provides access from both mobile and static devices including smart phones, tablets, laptops, and PCs from any location with Web access. The system can be stored in the cloud or on a dedicated server within the organisation network.<\/h2><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:31px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1250\" height=\"1000\" title=\"CTMS\" src=\"https:\/\/biglinksa.com\/digidata\/wp-content\/uploads\/2022\/09\/CTMS.png\" data-orig-src=\"https:\/\/biglinksa.com\/digidata\/wp-content\/uploads\/2022\/09\/CTMS.png\" alt class=\"lazyload img-responsive wp-image-389\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271250%27%20height%3D%271000%27%20viewBox%3D%270%200%201250%201000%27%3E%3Crect%20width%3D%271250%27%20height%3D%271000%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/biglinksa.com\/digidata\/wp-content\/uploads\/2022\/09\/CTMS-200x160.png 200w, https:\/\/biglinksa.com\/digidata\/wp-content\/uploads\/2022\/09\/CTMS-400x320.png 400w, https:\/\/biglinksa.com\/digidata\/wp-content\/uploads\/2022\/09\/CTMS-600x480.png 600w, https:\/\/biglinksa.com\/digidata\/wp-content\/uploads\/2022\/09\/CTMS-800x640.png 800w, https:\/\/biglinksa.com\/digidata\/wp-content\/uploads\/2022\/09\/CTMS-1200x960.png 1200w, https:\/\/biglinksa.com\/digidata\/wp-content\/uploads\/2022\/09\/CTMS.png 1250w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 600px\" \/><\/span><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1185.6px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:31px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5.76%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Key Functionality<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-1\"><p>Multiple Trials<br \/><span style=\"background-color: rgba(255, 255, 255, 0); color: var(--body_typography-color); font-family: var(--body_typography-font-family); font-size: var(--body_typography-font-size); font-style: var(--body_typography-font-style,normal); font-weight: var(--body_typography-font-weight); letter-spacing: var(--body_typography-letter-spacing);\">Multiple clinical trials are managed simultaneously. The solution maintains the complete history of each trial for an indefinite period.<\/span><\/p><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:31px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5.76%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Privacy<br \/><\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-2\"><p><span style=\"background-color: rgba(255, 255, 255, 0); color: var(--body_typography-color); font-family: var(--body_typography-font-family); font-size: var(--body_typography-font-size); font-style: var(--body_typography-font-style,normal); font-weight: var(--body_typography-font-weight); letter-spacing: var(--body_typography-letter-spacing);\">Biographical details are secured for access by authorized personnel for emergency contact, the initial collection of identity data and contact details during enrollment are hidden.<\/span><\/p><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:31px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5.76%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-5 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Participant Identification<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-3\"><p>At all points of contact the Participant is identified by manually inserting the unique participant code or the use of biometric scanning. Biometric scanning is also used as a means of electronic signature at necessary points in the trial process.<\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-4 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1185.6px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:31px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5.76%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-6 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Documentation and Images<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-4\"><p>As per GCP guidelines and regulations, advanced document management facilities control images\/photographs of:<\/p>\n<p>Test Results<\/p>\n<p>Participant and Clinical Staff supporting   documentation<\/p>\n<p>Clinical Trial Sponsor documentation<\/p>\n<p>Contracts<\/p>\n<p>IP information documents<\/p>\n<p>SAE reports<\/p>\n<p>These images can be scanned or imported into the system. Documents are consolidated with trial data.<\/p><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:31px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5.76%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-7 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Active Participant Messaging (SMS or USSD)<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-5\"><p>The DigiData Workflow Management Solution allows for prescribed data captured by clinical staff to be routed to assigned management staff such as the Principal Investigator for review and approval\/acceptance\/action.<\/p>\n<p>The workflow will also initiate follow-up tasks to the locator team for missed visits.<\/p>\n<p>Administration staff are notified when a participant visit is completed for and that the stipend can now be paid and recorded.<\/p>\n<p>This workflow routing can be accompanied by an SMS message or an email to the receiving party to alert them that a response action is required.<\/p><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:31px;--awb-spacing-right-large:5.76%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5.76%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-8 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Process Workflow Management<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-6\"><p>A comprehensive logging and messaging capability to send messages to participants including notification and reminders of scheduled visits and\/or missed appointments.<\/p>\n<p>Notifications are also generated in instances where an adverse test result indicates that the participant seek external medical intervention or return to the facility for intervention.<\/p>\n<p>Messaging can be extended to include active monitoring of participant compliance through an interactive USSD platform which requires confirmation by a participant that the IP has been taken.<\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-5 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1185.6px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-9 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:31px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-9 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Active Clinical Staff Messaging<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-7\"><p>The system provides a similar comprehensive logging and messaging capability that communicates to trial staff and management. These messages typically notify requests for intervention as part of the process or request a review of participant examinations or test results. They would also include requests for review and authorisation.<\/p><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-10 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:31px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-10 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Selective Data Downloads<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-8\"><p>In the process of tracking the progression of a Trial, the history of a Participant or the deployment of a Staff Member, the Dashboard provides a unique caopability. At the point that the system displays the required data at the detail level that is required, the simple selection of a &#8216;Download&#8217; option on the Dashboard screen extracts the data from the Dashboard and inserts it automatically into an Excel spreadsheet. This can then be used to support unique reporting and analysis.<\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-6 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1185.6px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-11 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:31px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-11 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Randomisation and Stratification<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-9\"><p>During the configuration of a Clinical Trial, The Group definition supports the definition of the Stratification criteria as well as specific selection criteria as required uniquely for each Clinical Trial. Once defined, the system will randomly automatically allocate Participants to each group. The system conforms to double blinding principles and the Group allocation of the Participant is maintained confidentially in the system and only used for Trial progression reporting. Selected management will have access to the participant group information.<\/p><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-12 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:21px;--awb-bg-position:center center;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:31px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-12 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-margin-top-small:0px;--awb-margin-right-small:0px;--awb-margin-bottom-small:20px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Custom Query Analysis<\/h2><\/div><div class=\"fusion-separator fusion-has-icon fusion-full-width-sep\" style=\"align-self: flex-start;margin-right:auto;margin-top:20px;margin-bottom:15px;width:100%;max-width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><span class=\"icon-wrapper\" style=\"border-color:var(--awb-color5);background-color:rgba(255,255,255,0);font-size:16px;width: 1.75em; height: 1.75em;border-width:1px;padding:1px;margin-top:-0.5px\"><i class=\"fa-star fas\" style=\"font-size: inherit;color:var(--awb-color5);\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-10\"><p>DigiDataCT provides a Query Analyser that supplements the Dashboard. The Query Analyser allows unique and targeted queries to be built based on any criteria and data in the system. The query will execute and return the selected results required. The query can be stored for re-use.<\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-325","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/biglinksa.com\/digidata\/wp-json\/wp\/v2\/pages\/325","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/biglinksa.com\/digidata\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/biglinksa.com\/digidata\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/biglinksa.com\/digidata\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/biglinksa.com\/digidata\/wp-json\/wp\/v2\/comments?post=325"}],"version-history":[{"count":18,"href":"https:\/\/biglinksa.com\/digidata\/wp-json\/wp\/v2\/pages\/325\/revisions"}],"predecessor-version":[{"id":402,"href":"https:\/\/biglinksa.com\/digidata\/wp-json\/wp\/v2\/pages\/325\/revisions\/402"}],"wp:attachment":[{"href":"https:\/\/biglinksa.com\/digidata\/wp-json\/wp\/v2\/media?parent=325"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}