{"id":4199,"date":"2020-05-25T10:54:13","date_gmt":"2020-05-25T17:54:13","guid":{"rendered":"https:\/\/www.cloudbyz.com\/blog\/?p=4199"},"modified":"2023-06-06T12:31:40","modified_gmt":"2023-06-06T19:31:40","slug":"blending-the-power-of-cloudbyz-ctms-with-ibm-merge","status":"publish","type":"post","link":"https:\/\/www.cloudbyz.com\/resources\/digital-transformation\/blending-the-power-of-cloudbyz-ctms-with-ibm-merge\/","title":{"rendered":"Blending the Power of CTMS with IBM Merge"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Clinical Trials, slowly but surely are becoming the new talking point of our generation. Even the teenagers of this contemporary age were discussing and searching about the clinical trials over the internet. Many of the world\u2019s powerful bureaucracies are closely monitoring the curiosity spinning around clinical trials.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">What\u2019s the basis for such significance?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The planet slowed to a standstill because of the COVID-19 and the global economy is at its highest peril. The only ray of hope is the ongoing clinical trials for the COVID vaccine that has been carried out by various pharmaceutical firms to save human society from this pandemic.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">What makes CTMS a staunch system?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Clinical Trial Management Software (CTMS) helps to organize clinical trials from all regards including collecting patient data, scheduling appointments, data reporting, analysis of records, and data management.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">An efficient CTMS that usually includes most or all of these features:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Account Management<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Investigator Database Management\/portal<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Study Management<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Budget Management<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Site Management<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Subject Enrollment<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Subject Visits<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Monitoring Reports<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Project Management<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Protocol Events<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Adverse Events<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">CRF\/eCRF<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">eTMF<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Drug and device Accountability<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Real-time Analytics<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">eCOA\/ePRO<\/span><\/li>\n<\/ul>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-15395\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/Banner-Blue-Bg-1-1-1024x512-1.png\" alt=\"\" width=\"1024\" height=\"512\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/Banner-Blue-Bg-1-1-1024x512-1.png 1024w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/Banner-Blue-Bg-1-1-1024x512-1-300x150.png 300w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/Banner-Blue-Bg-1-1-1024x512-1-768x384.png 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/p>\n<p><span style=\"font-weight: 400;\">In addition to that, a sound CTMS can leverage the features of third-party EDC systems like IBM Merge, Medidata RAVE, ClinCapture, OpenClinica, RedCap, etc which makes it a flexible and powerful tool in the market.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">New technologies will always drive the businesses to make the most out of it. With CTMS specific to CTMS, it is essential nowadays to have the system compatible with the EDC to bring the study-specific details to the clinical trial systems that can help to reduce the time and cost and also accelerate the processes to bring the therapies to the market faster.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">CTMS &amp; IBM Merge<\/span><\/p>\n<p><span style=\"font-weight: 400;\">IBM Clinical Development, a cloud-based data management platform that has Electronic Data Capture (EDC) in place. The platform offers solutions that cover the entire clinical study \u2013 from startup to submission. It helps teams to gather, analyze, and manage data with deep analytics irrespective of the size and complexity.<\/span><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-15397\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/additionalOfferingImg__2_f8ccfa30-0d01-427b-9e43-eb4e66bd5869-1024x576-1.jpg\" alt=\"\" width=\"1024\" height=\"576\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/additionalOfferingImg__2_f8ccfa30-0d01-427b-9e43-eb4e66bd5869-1024x576-1.jpg 1024w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/additionalOfferingImg__2_f8ccfa30-0d01-427b-9e43-eb4e66bd5869-1024x576-1-300x169.jpg 300w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/additionalOfferingImg__2_f8ccfa30-0d01-427b-9e43-eb4e66bd5869-1024x576-1-768x432.jpg 768w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/additionalOfferingImg__2_f8ccfa30-0d01-427b-9e43-eb4e66bd5869-1024x576-1-800x450.jpg 800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/p>\n<p><span style=\"font-weight: 400;\">The integration of a CTMS with the IBM Clinical Development can bring in the data in a hassle-free way and map the data across various entities to remodel it and visualize it in a coherent view.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Some of the aspects of the IBM Clinical Development include patient engagement, medical coding, data integration, reporting, and analytics.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Business Use Cases:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cloudbyz CTMS is used to manage efficient and seamless clinical operations and EDC systems are used for accurate clinical data capture.<\/span><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Subjects<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">As subjects are screened and enrolled, subject data is brought over from EDC to CTMS to track enrollment metrics including screened, screen-failed, and successfully enrolled, to make sure subject enrollment is on track to meet the planned target and milestones.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Subjects data is also used in CTMS to track enrollment rate, screen failure rate, and generating payments for each subject enrollment and screen failure.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Subject data in CTMS is also used during monitoring activities to track subjects monitored as part of the trip reports which will be filed in eTMF.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Subject Visits and Procedure<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Upon successful enrollment, subject visit and procedure data are brought over to CTMS for generating payments associated with each visit and procedure.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Visits and Procedure data are also used in CTMS as part of monitoring and trip reports.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">eCRF<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">eCRF data is brought over to CTMS from EDC to generate payments associated with each eCRF completion.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">eCRF data is also used for source data verification (SDV) during monitoring visits and generation of trip reports.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Adverse Events<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bringing Adverse Events into CTMS from EDC helps the clinical operations team to keep a close tab on tracking and response planning. Via automated workflow in CTMS, the clinical operations team will be able to deploy rapid response plans and report Adverse Events to sponsors and regulatory agencies promptly and file all Adverse Events in eTMF with a click of a button.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Having Adverse events in CTMS helps in risk management as well.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Protocol Deviations<\/span>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Having visibility to protocol deviations in CTMS helps the clinical operations team to quickly deploy response planning including corrective action and preventive (CAPA) by leveraging automated workflow and task assignments. Track and report as part of monitoring reports and notify sponsors and regulatory agencies.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Integrated CTMS and EDC help in enabling end-to-end process automation and real-time visibility and insight help Sponsors, CRO, and Sites to collaborate systematically and constructively across clinical research processes and helps improve quality, increase efficiency and plummeted cost and time throughout the clinical research.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">How can the two systems interlace?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cloudbyz CTMS can make a connection with the IBM Merge through the following steps:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Callout to get the access token.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Check the callout response.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Callout to get the list of subjects.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Map the subjects in the Salesforce system.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">With the help of OAuth 2.0, the clinical trial system can authenticate with the IBM Clinical development and grant access to register it as a trusted third-party system. If authorization is granted, we can use callouts to fetch the response from the IBM Merge which makes it easy for the gathering of study details.<\/span><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-15398\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/image1-1024x886-1.png\" alt=\"\" width=\"1024\" height=\"886\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/image1-1024x886-1.png 1024w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/image1-1024x886-1-300x260.png 300w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/image1-1024x886-1-768x665.png 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Request URL<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Request Type<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Request Header<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Account credentials\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-4227 size-full aligncenter\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/oauth2-caseflow.png\" alt=\"\" width=\"624\" height=\"457\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/oauth2-caseflow.png 624w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/oauth2-caseflow-300x220.png 300w\" sizes=\"(max-width: 624px) 100vw, 624px\" \/><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">(Username and Password)<\/span><span style=\"font-weight: 400;\">Authentication with IBM Merge:<\/span><span style=\"font-weight: 400;\">Authenticating the IBM Merge with Cloudbyz is the kick-off point for making the handshake. For doing so, we need the following parameters.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Fetching Subject data from IBM Merge:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">IBM Merge can help companies for early-phase trials i.e, study resources, case report forms. Also it provides the ability for the systems to capture data accurately and present it to users quickly.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For fetching the subject data from EDC to the clinical trials, the Salesforce system (CTMS) will have to request the required parameters as follows.<\/span><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Request URL<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Request Type<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Request Header<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Auth Code that is obtained from the OAuth 2.0 Authorization.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-15399 size-full\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/image2-860x1024-1.png\" alt=\"\" width=\"860\" height=\"1024\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/image2-860x1024-1.png 860w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/image2-860x1024-1-252x300.png 252w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/05\/image2-860x1024-1-768x914.png 768w\" sizes=\"(max-width: 860px) 100vw, 860px\" \/><\/p>\n<p><span style=\"font-weight: 400;\">The final word is,<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Adding new technologies to the system should accelerate the efficiency and lighten the time complexity and cost factor. But most of the time, it is happening the other way around. Advanced technologies, when added to the existing systems, result in many complications. So, after deep analysis and assessments, a sound CTMS product can leverage the technical services provided by the IBM Merge to make the CTMS more flexible and compatible with no dawdles.<\/span><\/p>\n\n\n\n\n\n","protected":false},"excerpt":{"rendered":"<p>Clinical Trials, slowly but surely are becoming the new talking point of our generation. Even the teenagers of this contemporary age were discussing and searching about the clinical trials over the internet. Many of the world\u2019s powerful bureaucracies are closely monitoring the curiosity spinning around clinical trials. What\u2019s the basis for such significance? The planet [&hellip;]<\/p>\n","protected":false},"author":30,"featured_media":8526,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"off","ocean_gallery_id":[],"footnotes":"","spc_primary_category":0},"categories":[267,3,262,271,166],"tags":[143,130,55,131,156,157,144,145,142],"acf":[],"aioseo_notices":[],"secondary_thumbnail":null,"_links":{"self":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/4199"}],"collection":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/users\/30"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/comments?post=4199"}],"version-history":[{"count":1,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/4199\/revisions"}],"predecessor-version":[{"id":15400,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/4199\/revisions\/15400"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/media\/8526"}],"wp:attachment":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/media?parent=4199"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/categories?post=4199"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/tags?post=4199"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}