{"id":215,"date":"2026-01-06T11:51:40","date_gmt":"2026-01-06T11:51:40","guid":{"rendered":"https:\/\/phloxpvmed.co.uk\/?page_id=215"},"modified":"2026-01-06T18:00:19","modified_gmt":"2026-01-06T18:00:19","slug":"aggregate-reports","status":"publish","type":"page","link":"https:\/\/phloxpvmed.co.uk\/?page_id=215","title":{"rendered":"Aggregate reports"},"content":{"rendered":"\n<p class=\"has-small-font-size\">Phlox PVMed Consultancy has decades of expertise in the preparation of aggregate reports that are aligned with other documents such as Investigator Brochures, Company Core Datasheets and product Risk Managment Plans, with a track record of the report being accepted by regulatory agencies without further comment or requests for change or further information. <\/p>\n\n\n\n<div class=\"wp-block-cover is-light\" style=\"min-height:50px;aspect-ratio:unset;\"><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim\" style=\"background-color:#d7b5cc\"><\/span><img loading=\"lazy\" decoding=\"async\" width=\"625\" height=\"625\" src=\"https:\/\/phloxpvmed.co.uk\/wp-content\/uploads\/2024\/01\/screenshot_20240109_155047_docs-624970824-e1708600503899.jpg\" class=\"wp-block-cover__image-background wp-post-image\" alt=\"\" data-object-fit=\"cover\" srcset=\"https:\/\/phloxpvmed.co.uk\/wp-content\/uploads\/2024\/01\/screenshot_20240109_155047_docs-624970824-e1708600503899.jpg 625w, https:\/\/phloxpvmed.co.uk\/wp-content\/uploads\/2024\/01\/screenshot_20240109_155047_docs-624970824-e1708600503899-300x300.jpg 300w, https:\/\/phloxpvmed.co.uk\/wp-content\/uploads\/2024\/01\/screenshot_20240109_155047_docs-624970824-e1708600503899-150x150.jpg 150w\" sizes=\"auto, (max-width: 625px) 100vw, 625px\" \/><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<p class=\"has-text-align-center has-base-color has-text-color has-link-color has-large-font-size wp-elements-5433135653ebe8de92253b2b3ab7610f\">We can help with any type of data aggregation and report<\/p>\n<\/div><\/div>\n\n\n\n<ul class=\"wp-block-list has-small-font-size\">\n<li>Periodic safety update reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) to ICH E2C requirements<\/li>\n\n\n\n<li>Development safety update reports (DSURs) to ICH E2F requirements<\/li>\n\n\n\n<li>Risk Managment Plans to EU, Australian and UK requirements<\/li>\n\n\n\n<li>Risk Evaluation and Mitigation Strategies (REMS) to US FDA requirements<\/li>\n\n\n\n<li>Health Authority Safety Review Request (HASRQ) response documents<\/li>\n<\/ul>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-cover is-light\" style=\"min-height:50px;aspect-ratio:unset;\"><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim\" style=\"background-color:#d7b5cc\"><\/span><img loading=\"lazy\" decoding=\"async\" width=\"625\" height=\"625\" src=\"https:\/\/phloxpvmed.co.uk\/wp-content\/uploads\/2024\/01\/screenshot_20240109_155047_docs-624970824-e1708600503899.jpg\" class=\"wp-block-cover__image-background wp-post-image\" alt=\"\" data-object-fit=\"cover\" srcset=\"https:\/\/phloxpvmed.co.uk\/wp-content\/uploads\/2024\/01\/screenshot_20240109_155047_docs-624970824-e1708600503899.jpg 625w, https:\/\/phloxpvmed.co.uk\/wp-content\/uploads\/2024\/01\/screenshot_20240109_155047_docs-624970824-e1708600503899-300x300.jpg 300w, https:\/\/phloxpvmed.co.uk\/wp-content\/uploads\/2024\/01\/screenshot_20240109_155047_docs-624970824-e1708600503899-150x150.jpg 150w\" sizes=\"auto, (max-width: 625px) 100vw, 625px\" \/><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<p class=\"has-text-align-center has-base-color has-text-color has-link-color has-large-font-size wp-elements-e0cdf46f91ff1fcec212bc020a3c5b15\">We provide experience to optimise efficiency and quality<\/p>\n<\/div><\/div>\n\n\n\n<ul class=\"wp-block-list has-small-font-size\">\n<li>Create the initial strategy, preparation and production of first DSUR, PBRERs and RMPs<\/li>\n\n\n\n<li>Work with vendors to order and QC reports for inclusion in correct format<\/li>\n\n\n\n<li>Create company specific templates<\/li>\n\n\n\n<li>Support single reports or write multiple aligned reports<\/li>\n\n\n\n<li>Provide medical writing and document management and facilitation<\/li>\n<\/ul>\n\n\n\n<div style=\"height:33px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\">Contact us to discuss your requirements<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Phlox PVMed Consultancy has decades of expertise in the preparation of aggregate reports that are aligned with other documents such as Investigator Brochures, Company Core Datasheets and product Risk Managment Plans, with a track record of the report being accepted by regulatory agencies without further comment or requests for change or further information.<\/p>\n","protected":false},"author":1,"featured_media":11,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-215","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=\/wp\/v2\/pages\/215","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=215"}],"version-history":[{"count":5,"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=\/wp\/v2\/pages\/215\/revisions"}],"predecessor-version":[{"id":244,"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=\/wp\/v2\/pages\/215\/revisions\/244"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=\/wp\/v2\/media\/11"}],"wp:attachment":[{"href":"https:\/\/phloxpvmed.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=215"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}