{"id":3762,"date":"2025-10-30T20:12:53","date_gmt":"2025-10-30T19:12:53","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=about-us-fgk-cro&#038;p=3762"},"modified":"2025-11-26T14:47:57","modified_gmt":"2025-11-26T13:47:57","slug":"algiax-case-study","status":"publish","type":"about-us-fgk-cro","link":"https:\/\/fgk-group.com\/de\/fgk-cro\/ueber-uns\/referenzen\/algiax-case-study\/","title":{"rendered":"Algiax Pharmaceuticals GmbH &#8211; CASE STUDY"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3762\" class=\"elementor elementor-3762 elementor-1677\" data-elementor-post-type=\"about-us-fgk-cro\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0c16dcf e-flex e-con-boxed e-con e-parent\" data-id=\"0c16dcf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c0923e4 elementor-widget elementor-widget-heading\" data-id=\"c0923e4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">FOCUS ON THE SOLUTIONS, NOT THE PROBLEM: PERSISTENCE FOR A NEW TREATMENT AGAINST NEUROPATHIC PAIN\n<\/h1>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bb929a0 e-con-full e-flex e-con e-child\" data-id=\"bb929a0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b0ca5c2 elementor-widget elementor-widget-heading\" data-id=\"b0ca5c2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Background<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62c8c0d elementor-widget elementor-widget-text-editor\" data-id=\"62c8c0d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>In a Phase IIa study of a treatment for peripheral neuropathic pain after certain surgeries, FGK managed 38 sites in 5 countries all over Europe and continuously analyzed the data gained under an adaptive study design.<\/p><p>Recruitment was completed after 51 months, with 162 participants screened and 106 subjects randomized. Although the recruitment period was longer than sponsor and investigators expected, FGK hardly changed the study team and worked continuously on the project together with the sponsor &#8211; from the initial planning to the study report.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a0890c7 elementor-widget elementor-widget-heading\" data-id=\"a0890c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Challenges &amp; FGK\u2019s solutions<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3da2f09 elementor-widget elementor-widget-text-editor\" data-id=\"3da2f09\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The project was facing a patient population very difficult to recruit as there are no central contact points for such patients.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0ed3517 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"0ed3517\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>FGK conducted a high-end feasibility<\/strong> with the intended patient population in Europe and identified  two additional countries with 6 sites in each, what additionally boosted the enrollment significantly.  <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">The cooperation with patient recruitment services brought further patients in all participating countries, but the game changer was the close cooperation between project team and study sites. <strong>Through continuous motivation and support, the sites succeeded in meeting the recruitment goal.<\/strong> <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd31314 elementor-widget elementor-widget-text-editor\" data-id=\"fd31314\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The primary endpoint was based on patient diaries. As an additional difficulty, patients had to wash out their existing and sometimes strong pain medication, a high commitment for their participation and retention.<\/p><p>In addition, the global COVID pandemic interrupted the smooth start with forcing the sites into lock down right after the Investigator Meeting.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c020996 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"c020996\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\"><strong>Again, FGK maintained very close collaboration with trial sites to ensure compliance and minimize drop-out rates by planning suitable visit dates as well as providing ideas for continuing patient motivation<\/strong><\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8c8d0e2 elementor-widget elementor-widget-text-editor\" data-id=\"8c8d0e2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The close cooperation between FGK, sponsor, sites and members of the IDMC also contributed to the ongoing trust of sites and patients<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-601a927 elementor-widget elementor-widget-heading\" data-id=\"601a927\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Project Outcome<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5452dcd elementor-widget elementor-widget-text-editor\" data-id=\"5452dcd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>It was clear from the beginning, that recruitment in this very difficult-to-recruit patient population would not be easy, but neither the sponsor, nor the investigators expected it to be so hard. There was always an open and constructive exchange at eye level on this topic. Corresponding change orders &#8211; due to the extension of the duration &#8211; were negotiated with a sense of proportionality and great mutual understanding.<\/p><p>Despite the long recruitment period of four years, there were hardly any personnel changes in the FGK team and the same PM who started the study also completed it. Rather, FGK has consistently responded very flexibly to the needs of the project and has always provided the required resources to ensure the project is optimally supported at any time.<\/p><p>And in the end, everyone in the team was really pleased with the positive study results.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e5fe580 e-con-full e-flex e-con e-child\" data-id=\"e5fe580\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-eda86d7 e-con-full elementor-hidden-mobile e-flex e-con e-child\" data-id=\"eda86d7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-113a060 e-con-full e-flex e-con e-child\" data-id=\"113a060\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42ea475 elementor-widget elementor-widget-heading\" data-id=\"42ea475\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Julia Krasnopolski<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9ac45d9 elementor-widget elementor-widget-heading\" data-id=\"9ac45d9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Project Manager at FGK<\/p>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a383bf elementor-widget elementor-widget-text-editor\" data-id=\"5a383bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><em>&#8222;We overcame every obstacle and challenge with reliable commitment from our project team and turned adversity into success. The journey was tough sometimes, but the result was worth every effort. In the end, our client&#8217;s satisfaction proved that no challenge is too great when we work together as a team!&#8220;<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a543484 e-con-full e-flex e-con e-child\" data-id=\"a543484\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-6b47cfd e-con-full e-flex e-con e-child\" data-id=\"6b47cfd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b9e284e elementor-widget elementor-widget-image\" data-id=\"b9e284e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"247\" src=\"https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/Logo_Algiax.png\" class=\"attachment-large size-large wp-image-3761\" alt=\"\" srcset=\"https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/Logo_Algiax.png 886w, https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/Logo_Algiax-300x92.png 300w, https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/Logo_Algiax-768x237.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<div class=\"elementor-element elementor-element-594bed1 e-con-full e-flex e-con e-child\" data-id=\"594bed1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-29ca219 elementor-widget elementor-widget-heading\" data-id=\"29ca219\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Dr. Guido Koopmans, Algiax Pharmaceuticals GmbH<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-406a346 elementor-widget elementor-widget-heading\" data-id=\"406a346\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">CSO<\/p>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9641e52 elementor-widget elementor-widget-text-editor\" data-id=\"9641e52\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><em>&#8222;As the Chief\u2002Scientific Officer from <strong><a href=\"http:\/\/www.algiax.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Algiax<\/a><\/strong>, I would like to take this opportunity to acknowledge the excellent performance provided by FGK on our recent clinical trial. This was a very challenging project, not only because of the complexity of the indication, but also because this was the first time we\u2002would experience the interaction with the patients and sites facing the COVID Pandemic. At all times the FGK project team exhibited expertise, and dedicated initiative and was highly\u2002dependable. Their professional attitude and\u2002commitment helped in the successful execution of this demanding study. We are grateful for their partnership and look forward to future collaborations.&#8220;<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6555284 elementor-widget elementor-widget-text-editor\" data-id=\"6555284\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>If you are looking for a dedicated team of experts who support your study sites in the best possible way,<strong>\u00a0<a href=\"\/de\/fgk-cro\/fgk-cro-kontakt\/\">get in touch with us!<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"parent":3758,"menu_order":0,"template":"","class_list":["post-3762","about-us-fgk-cro","type-about-us-fgk-cro","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Algiax Pharmaceuticals GmbH - CASE STUDY - FGK Group<\/title>\n<meta name=\"description\" content=\"How FGK Clinical Research successfully managed a Phase II study\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fgk-group.com\/de\/fgk-cro\/ueber-uns\/referenzen\/algiax-case-study\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Algiax Pharmaceuticals GmbH - CASE STUDY - FGK Group\" \/>\n<meta property=\"og:description\" content=\"How FGK Clinical Research successfully managed a Phase II study\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fgk-group.com\/de\/fgk-cro\/ueber-uns\/referenzen\/algiax-case-study\/\" \/>\n<meta property=\"og:site_name\" content=\"FGK Group\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-26T13:47:57+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/fgk-group.com\/wp-content\/uploads\/2025\/08\/Logo_Algiax.png\" \/>\n\t<meta property=\"og:image:width\" content=\"886\" \/>\n\t<meta property=\"og:image:height\" content=\"273\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"4\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/algiax-case-study\\\/\",\"url\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/algiax-case-study\\\/\",\"name\":\"Algiax Pharmaceuticals GmbH - CASE STUDY - FGK Group\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/algiax-case-study\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/algiax-case-study\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/fgk-group.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/Logo_Algiax.png\",\"datePublished\":\"2025-10-30T19:12:53+00:00\",\"dateModified\":\"2025-11-26T13:47:57+00:00\",\"description\":\"How FGK Clinical Research successfully managed a Phase II study\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/algiax-case-study\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/algiax-case-study\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/algiax-case-study\\\/#primaryimage\",\"url\":\"https:\\\/\\\/fgk-group.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/Logo_Algiax.png\",\"contentUrl\":\"https:\\\/\\\/fgk-group.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/Logo_Algiax.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/algiax-case-study\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"About Us\",\"item\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Referenzen\",\"item\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/fgk-cro\\\/ueber-uns\\\/referenzen\\\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Algiax Pharmaceuticals GmbH &#8211; 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