{"id":8049,"date":"2025-01-09T00:12:05","date_gmt":"2025-01-09T00:12:05","guid":{"rendered":"https:\/\/bostonsp.com\/?page_id=8049"},"modified":"2025-01-09T00:12:08","modified_gmt":"2025-01-09T00:12:08","slug":"leveraging-real-world-evidence-for-indication-expansion","status":"publish","type":"page","link":"https:\/\/bostonsp.com\/index.php\/leveraging-real-world-evidence-for-indication-expansion\/","title":{"rendered":"Leveraging Real-World Evidence for Indication Expansion"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"8049\" class=\"elementor elementor-8049\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-6abf850 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6abf850\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3bbe958 elementor-invisible\" data-id=\"3bbe958\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:200}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9577958 elementor-widget elementor-widget-heading\" data-id=\"9577958\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Leveraging Real-World Evidence for Indication Expansion<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-169eb15 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"169eb15\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-93b741d elementor-invisible\" data-id=\"93b741d\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInLeft&quot;,&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8c37c49 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"8c37c49\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Regulatory Bodies Increasingly Recognize the Value of RWE in Decision-making Processes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d3a9c41 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d3a9c41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Real-World Evidence (RWE) plays an increasing role in recent regulatory decision-making. Instead of conducting time-consuming and costly clinical trials, RWE can offer comprehensive insights from diverse patient populations to potentially accelerate regulatory approvals, providing a cost-effective indication expansion option that must be considered. RWE can also be a valuable pairing to insufficient RCT outcomes.<\/p><p>BSP excels in leveraging RWE, including for this purpose. We have extensive experience evaluating and utilizing a wide range of real-world data sources, including clinical trials, claims, electronic health records, registries and published studies. Our diverse, capable team has a proven track record of supporting agency communications to meet our clients\u2019 regulatory objectives.<\/p><h5 style=\"text-align: center;\"><span style=\"color: #2f7889;\"><em>BSP is actively pursuing label expansion initiatives for existing treatments using real-world evidence (RWE) in both rare and chronic disease spaces<\/em><\/span><\/h5>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-ac6c12d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ac6c12d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c117b4f\" data-id=\"c117b4f\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2616d7f elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"2616d7f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">BSP's framework for evaluating RWE is a three-pronged approach, which enables us to ensure we have the right data to fit the regulatory needs<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c3cf64 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"2c3cf64\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h4><span style=\"color: #ffffff;\">\u00a0 \u00a0 For instance, with the FDA:<\/span><\/h4>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-db92f2b elementor-invisible elementor-widget elementor-widget-image\" data-id=\"db92f2b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1918\" height=\"858\" src=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/10\/BSP-three-pronged-approach.png\" class=\"attachment-full size-full wp-image-8062\" alt=\"\" srcset=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/10\/BSP-three-pronged-approach.png 1918w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/10\/BSP-three-pronged-approach-300x134.png 300w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/10\/BSP-three-pronged-approach-1024x458.png 1024w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/10\/BSP-three-pronged-approach-768x344.png 768w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/10\/BSP-three-pronged-approach-1536x687.png 1536w\" sizes=\"(max-width: 1918px) 100vw, 1918px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cfc133a elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cfc133a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7cdf59a elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"7cdf59a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h4><span style=\"color: #ffffff;\">\u00a0 \u00a0 BSP&#8217;s Workflow:<\/span><\/h4>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-inner-section elementor-element elementor-element-9c615db elementor-section-full_width elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"9c615db\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-20 elementor-inner-column elementor-element elementor-element-692db29\" data-id=\"692db29\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b5942c6 elementor-widget elementor-widget-image\" data-id=\"b5942c6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1200\" height=\"1200\" src=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-meeting-7168989-2f7889.png\" class=\"attachment-full size-full wp-image-8085\" alt=\"\" srcset=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-meeting-7168989-2f7889.png 1200w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-meeting-7168989-2f7889-300x300.png 300w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-meeting-7168989-2f7889-1024x1024.png 1024w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-meeting-7168989-2f7889-150x150.png?crop=1 150w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-meeting-7168989-2f7889-768x768.png 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-20 elementor-inner-column elementor-element elementor-element-6a33b55\" data-id=\"6a33b55\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d4a0a39 elementor-widget elementor-widget-image\" data-id=\"d4a0a39\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-planning-5990579-2f7889-1024x1024.png\" class=\"attachment-large size-large wp-image-8080\" alt=\"\" srcset=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-planning-5990579-2f7889-1024x1024.png 1024w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-planning-5990579-2f7889-300x300.png 300w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-planning-5990579-2f7889-150x150.png?crop=1 150w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-planning-5990579-2f7889-768x768.png 768w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-planning-5990579-2f7889.png 1200w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-20 elementor-inner-column elementor-element elementor-element-6d48366\" data-id=\"6d48366\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bf19c5a elementor-widget elementor-widget-image\" data-id=\"bf19c5a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-court-6013208-2f7889-1024x1024.png\" class=\"attachment-large size-large wp-image-8082\" alt=\"\" srcset=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-court-6013208-2f7889-1024x1024.png 1024w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-court-6013208-2f7889-300x300.png 300w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-court-6013208-2f7889-150x150.png?crop=1 150w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-court-6013208-2f7889-768x768.png 768w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-court-6013208-2f7889.png 1200w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-20 elementor-inner-column elementor-element elementor-element-95bbc78\" data-id=\"95bbc78\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e600b36 elementor-widget elementor-widget-image\" data-id=\"e600b36\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-implementation-6813592-2f7889-1024x1024.png\" class=\"attachment-large size-large wp-image-8081\" alt=\"\" srcset=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-implementation-6813592-2f7889-1024x1024.png 1024w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-implementation-6813592-2f7889-300x300.png 300w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-implementation-6813592-2f7889-150x150.png?crop=1 150w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-implementation-6813592-2f7889-768x768.png 768w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-implementation-6813592-2f7889.png 1200w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-20 elementor-inner-column elementor-element elementor-element-e34379e\" data-id=\"e34379e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cb5090a elementor-widget elementor-widget-image\" data-id=\"cb5090a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-regulatory-6173845-2f7889-1024x1024.png\" class=\"attachment-large size-large wp-image-8083\" alt=\"\" srcset=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-regulatory-6173845-2f7889-1024x1024.png 1024w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-regulatory-6173845-2f7889-300x300.png 300w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-regulatory-6173845-2f7889-150x150.png?crop=1 150w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-regulatory-6173845-2f7889-768x768.png 768w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/11\/noun-regulatory-6173845-2f7889.png 1200w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-386bfdb elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"386bfdb\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h6 style=\"text-align: center;\">Kickoff\/Planning<\/h6><ul><li>Review current evidence and client regulatory strategy options<\/li><li>Conduct stakeholder\/KOL interviews<\/li><li>Formulate regulatory strategies and likelihood of success<\/li><li>Align chosen strategy with internal objectives<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ec804d elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"2ec804d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h6 style=\"text-align: center;\">Study plan development<\/h6><ul><li>Develop study protocol framework<\/li><li>Identify potential datasets that support study design<\/li><li>Evaluate study feasibility for robust cohorts\/required data fields <\/li><li>Draft statistical analysis plan (SAP)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0dc64a1 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"0dc64a1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h6 style=\"text-align: center;\">Propose plans to Regulatory Agency<\/h6><ul><li>Prepare briefing documents <\/li><li>Schedule and attend meetings with the Agency<\/li><li>Answer Agency queries or counter proposals<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a0dc3d8 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"a0dc3d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h6 style=\"text-align: center;\">Implementation<\/h6><ul><li>Finalize RWE study protocol\/SAP<\/li><li>Execute RWE analysis<\/li><li>Conduct regular progress meetings with clients<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-897c159 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"897c159\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h6 style=\"text-align: center;\">Regulatory submission<\/h6><ul><li>Compile study findings <\/li><li>Develop submission package for Agency<\/li><li>Answer Agency queries or counter proposals<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-de21435 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"de21435\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-13e1b31 elementor-invisible\" data-id=\"13e1b31\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-865926f elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"865926f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Relevant Experience and Past Work<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-inner-section elementor-element elementor-element-b319408 elementor-section-full_width elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"b319408\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-ce2e340\" data-id=\"ce2e340\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0db17db elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"0db17db\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"600\" src=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/12\/Indication-Case-1.png\" class=\"attachment-large size-large wp-image-8117\" alt=\"\" srcset=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/12\/Indication-Case-1.png 800w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/12\/Indication-Case-1-300x225.png 300w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/12\/Indication-Case-1-768x576.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-4dac59d\" data-id=\"4dac59d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b57503e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"b57503e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5 style=\"font-family: var( --e-global-typography-7044a64-font-family ), Sans-serif; font-weight: var( --e-global-typography-7044a64-font-weight ); line-height: var( --e-global-typography-7044a64-line-height ); font-size: var( --e-global-typography-7044a64-font-size ); letter-spacing: normal; word-spacing: 0px;\">Case 1. Our client sought to achieve indication extension for their plasma-derived products by leveraging RWE<\/h5><p>BSP&#8217;s Approach:<\/p><ul style=\"font-size: 16px; background-color: #ffffff;\"><li style=\"font-size: 16px;\">Identify, critique, and estimate the likelihood of regulatory success for each potential strategy to establish a rank order of the options<\/li><li style=\"font-size: 16px;\">Conduct feasibility assessment of potential RWE source data<\/li><li style=\"font-size: 16px;\">Make a successful proposal to FDA to achieve the agreed research plan for each prioritized initiative<\/li><li style=\"font-size: 16px;\">Conduct any necessary agreed analyses<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-inner-section elementor-element elementor-element-f2faf05 elementor-section-full_width elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"f2faf05\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-f38b975\" data-id=\"f38b975\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fe5314f elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"fe5314f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"600\" src=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/12\/Indication-Case-2.png\" class=\"attachment-large size-large wp-image-8116\" alt=\"\" srcset=\"https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/12\/Indication-Case-2.png 800w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/12\/Indication-Case-2-300x225.png 300w, https:\/\/bostonsp.com\/wp-content\/uploads\/2024\/12\/Indication-Case-2-768x576.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-41263bd\" data-id=\"41263bd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e2583eb elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"e2583eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5 style=\"font-family: var( --e-global-typography-7044a64-font-family ), Sans-serif; font-weight: var( --e-global-typography-7044a64-font-weight ); line-height: var( --e-global-typography-7044a64-line-height ); font-size: var( --e-global-typography-7044a64-font-size ); letter-spacing: normal; word-spacing: 0px;\">Case 2.\u00a0<span style=\"color: var( --e-global-color-d49ac81 ); font-family: var( --e-global-typography-7044a64-font-family ), Sans-serif; font-size: var( --e-global-typography-7044a64-font-size ); font-weight: var( --e-global-typography-7044a64-font-weight ); font-style: var( --e-global-typography-b2ce6af-font-style ); text-transform: var( --e-global-typography-b2ce6af-text-transform );\">Our client conducted a pivotal clinical trial using a biologic in the neurosurgical space, the outcomes of which met primary safety endpoints but missed the primary efficacy endpoint. Therefore, they wished to explore the feasibility of label expansion harnessing RWE, among other possible regulatory strategies<\/span><\/h5><p style=\"color: #525252; font-family: Inter, sans-serif; font-size: 16px; font-weight: 400;\">BSP&#8217;s Approach:<\/p><ul style=\"font-size: 16px; background-color: #ffffff; color: #525252; font-family: Inter, sans-serif; font-weight: 400;\"><li style=\"font-size: 16px;\">Review the totality of all data available for the product, RWD analytics conducted to date, and patient exposures<\/li><li style=\"font-size: 16px;\">Conduct a targeted literature search for all published evidence that may be used to support a regulatory strategy and FDA filing<\/li><li style=\"font-size: 16px;\">Formulate potential strategies informed by available evidence; critique and estimate the likelihood of regulatory success of each one, to create a rank order of options<\/li><li style=\"font-size: 16px;\">Align with client on selected strategy<\/li><li style=\"font-size: 16px;\">Construct a proposal to FDA\/ meeting packet to support the prioritized strategy<\/li><li style=\"font-size: 16px;\">As needed, conduct any necessary agreed analyses post meeting to support filing<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-0aa30d3 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0aa30d3\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b9ba231 elementor-invisible\" data-id=\"b9ba231\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5274134 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"5274134\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Contact BSP today to explore how our unparalleled expertise in RWE can support your indication expansion program<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98fa230 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"98fa230\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>BSP is skilled in utilizing RWE to drive indication expansion. Our comprehensive approach integrates cutting-edge data analytics, clinical expertise, and regulatory insights to maximize the potential of existing therapies. In addition to supporting over 85 programs across various disease areas and drugs\/medical devices, we have successfully demonstrated creative solutions in situations with minimal precedence.<\/p><p>Partner with us to unlock new therapeutic potential and streamline regulatory pathways through the power of RWE.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e752ec5 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"e752ec5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-lg\" href=\"https:\/\/bostonsp.com\/index.php\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact Us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Regulatory Bodies Increasingly Recognize the Value of RWE in Decision-making Processes Real-World Evidence (RWE) plays an increasing role in recent regulatory decision-making. Instead of conducting time-consuming and costly clinical trials, RWE can offer comprehensive insights from diverse patient populations to potentially accelerate regulatory approvals, providing a cost-effective indication expansion option that must be considered. RWE [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"_acf_changed":false,"_eb_attr":"","om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"class_list":["post-8049","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bostonsp.com\/index.php\/wp-json\/wp\/v2\/pages\/8049","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bostonsp.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/bostonsp.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/bostonsp.com\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/bostonsp.com\/index.php\/wp-json\/wp\/v2\/comments?post=8049"}],"version-history":[{"count":59,"href":"https:\/\/bostonsp.com\/index.php\/wp-json\/wp\/v2\/pages\/8049\/revisions"}],"predecessor-version":[{"id":8129,"href":"https:\/\/bostonsp.com\/index.php\/wp-json\/wp\/v2\/pages\/8049\/revisions\/8129"}],"wp:attachment":[{"href":"https:\/\/bostonsp.com\/index.php\/wp-json\/wp\/v2\/media?parent=8049"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}