Domain > apoxes.com

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Date	IP Address
2025-12-09	35.214.204.151 (ClassC)

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Oversight & Quality Support for Biotech and Pharma/h1>p classuagb-desc-text>Independent consulting focused on safety, medical review, MedDRA coding, data quality, and targeted quality guidance to ensure your clinical trials are medically sound, compliant, and inspection-ready./p>/div>/div>/div>div classwp-block-uagb-container uagb-block-8e76fe38 alignfull uagb-is-root-container>div classwp-block-uagb-image uagb-block-6c51998c wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none>figure classwp-block-uagb-image__figure>img decodingasync data-srcsethttp://apoxes.com/wp-content/uploads/2024/09/g720b07ad64213cb5b97ef5b4ebeb06de645a96845633797898e9ab108cd4e5f82b8c7259f63f34f60c17828bdc40b42e10c5887029264328eb85229a063e5399_1280-1263422-1024x682.jpg ,http://apoxes.com/wp-content/uploads/2024/09/g720b07ad64213cb5b97ef5b4ebeb06de645a96845633797898e9ab108cd4e5f82b8c7259f63f34f60c17828bdc40b42e10c5887029264328eb85229a063e5399_1280-1263422.jpg 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titleg720b07ad64213cb5b97ef5b4ebeb06de645a96845633797898e9ab108cd4e5f82b8c7259f63f34f60c17828bdc40b42e10c5887029264328eb85229a063e5399_1280-1263422 loadinglazy roleimg/>/noscript>/figure>/div>/div>div classwp-block-uagb-container uagb-block-daf48b7a alignfull uagb-is-root-container>div classuagb-container-inner-blocks-wrap>div classwp-block-uagb-info-box uagb-block-bce261d5 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h2 classuagb-ifb-title>About Us/h2>/div>p classuagb-ifb-desc>At Apoxes, we provide specialized consulting services in clinical trial safety, medical monitoring, MedDRA medical coding, medical data review, and operational case processing, complemented by targeted quality and compliance support.br>Led by Pavol Fuček, MD — former Head of Quality Assurance & Pharmacovigilance and senior medical leader — Apoxes helps biotech and pharmaceutical organizations enhance the safety, medical integrity, and quality of their clinical development programs.br>Our goal is to deliver expert, flexible, and medically driven solutions that strengthen your study execution without unnecessary operational overhead./p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/about-us/ classuagb-infobox-cta-link ast-outline-button target_self relnoopener noreferrer styleborder-width:revert-layer onclickreturn true;>span classuagb-inline-editing>View More/span>/a>/div>/div>/div>/div>/div>div classwp-block-uagb-container uagb-layout-grid uagb-block-5d1ebe48 alignfull uagb-is-root-container>div classwp-block-uagb-image uagb-block-21c6d318 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none>figure classwp-block-uagb-image__figure>img decodingasync data-srcsethttp://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023-1024x682.jpg ,http://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023.jpg 780w, http://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023.jpg 360w sizesauto, (max-width: 480px) 150px srcdata:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7 data-srchttp://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023-1024x682.jpg altgel capsules, capsules, medicine classuag-image-1229 lazyload width1024 height682 titlege805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023 loadinglazy roleimg/>noscript>img decodingasync srcsethttp://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023-1024x682.jpg ,http://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023.jpg 780w, http://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023.jpg 360w sizesauto, (max-width: 480px) 150px srchttp://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023-1024x682.jpg altgel capsules, capsules, medicine classuag-image-1229 lazyload width1024 height682 titlege805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023 loadinglazy roleimg/>/noscript>/figure>/div>div classwp-block-uagb-info-box uagb-block-54072360 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top wp-block-uagb-info-box--has-margin>div classuagb-infobox-margin-wrapper>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h2 classuagb-ifb-title-prefix>Clinical Trial Safety Oversight/h2>p classuagb-ifb-title>Independent medical expertise to safeguard your studies from first patient in to database lock./p>/div>p classuagb-ifb-desc>Clinical trial safety oversight at Apoxes focuses on providing senior medical insight throughout the full lifecycle of a study. With extensive experience in product and clinical trial documents, AE/SAE evaluation, safety surveillance, and medical consistency review, we ensure that safety information is interpreted accurately, emerging risks are identified early, and critical decisions are medically sound. Our approach strengthens the reliability of your safety data, supports regulatory expectations, and enhances the overall execution and integrity of your clinical trial./p>/div>/div>/div>/div>div classwp-block-uagb-container uagb-layout-grid uagb-block-db4be87b alignfull uagb-is-root-container>div classwp-block-uagb-info-box uagb-block-5055817d uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h2 classuagb-ifb-title-prefix>Medical Data Review, MedDRA Coding & Medical Monitoring/h2>p classuagb-ifb-title>Accurate, medically grounded data review to ensure coherent, consistent, and high-quality clinical datasets./p>/div>p classuagb-ifb-desc>We provide comprehensive medical data review encompassing medical monitoring, MedDRA coding oversight, and end-to-end evaluation of clinical data across safety and efficacy domains. The focus is on clinical plausibility, consistency, and meaningful interpretation — ensuring that subject data, coding decisions, narratives, listings, and key endpoints align medically and support the study objectives. This integrated approach improves data quality, reduces rework at database lock, and enables sponsors to rely on clean, coherent, and medically validated datasets for regulatory submission and decision-making./p>/div>/div>div classwp-block-uagb-image uagb-block-78d79ae2 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none>figure classwp-block-uagb-image__figure>img decodingasync data-srcsethttp://apoxes.com/wp-content/uploads/2024/09/g1c669ea4bb5882e03d3bcba39b11bff6b6c1bc168718509fd24d46092c1a5a5a45a429ab51a021049a9ad029baf36085a39f541df3890091e776449f8a8621f7_1280-5146199-1024x750.jpg ,http://apoxes.com/wp-content/uploads/2024/09/g1c669ea4bb5882e03d3bcba39b11bff6b6c1bc168718509fd24d46092c1a5a5a45a429ab51a021049a9ad029baf36085a39f541df3890091e776449f8a8621f7_1280-5146199.jpg 780w, 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titleg1c669ea4bb5882e03d3bcba39b11bff6b6c1bc168718509fd24d46092c1a5a5a45a429ab51a021049a9ad029baf36085a39f541df3890091e776449f8a8621f7_1280-5146199 loadinglazy roleimg/>/noscript>/figure>/div>/div>div classwp-block-uagb-container uagb-layout-grid uagb-block-6598895d alignfull uagb-is-root-container>div classwp-block-uagb-image uagb-block-8b00aa1d wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none>figure classwp-block-uagb-image__figure>img decodingasync data-srcsethttp://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-683x1024.jpg ,http://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-scaled.jpg 780w, http://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-scaled.jpg 360w sizesauto, (max-width: 480px) 150px srcdata:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7 data-srchttp://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-683x1024.jpg altA sleek tablet with highlighted text and stylus on a wooden table, indoors. classuag-image-1291 lazyload width683 height1024 titlepexels-photo-5206034-5206034 loadinglazy roleimg/>noscript>img decodingasync srcsethttp://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-683x1024.jpg ,http://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-scaled.jpg 780w, http://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-scaled.jpg 360w sizesauto, (max-width: 480px) 150px srchttp://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-683x1024.jpg altA sleek tablet with highlighted text and stylus on a wooden table, indoors. classuag-image-1291 lazyload width683 height1024 titlepexels-photo-5206034-5206034 loadinglazy roleimg/>/noscript>/figure>/div>div classwp-block-uagb-info-box uagb-block-d4726e81 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top wp-block-uagb-info-box--has-margin>div classuagb-infobox-margin-wrapper>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h2 classuagb-ifb-title-prefix>Quality Support for Clinical Safety & Compliance/h2>p classuagb-ifb-title>Practical, targeted quality guidance designed to strengthen clinical and safety operations without unnecessary complexity./p>/div>p classuagb-ifb-desc>Apoxes offers focused quality support that complements safety and medical oversight activities, helping sponsors maintain compliance, refine internal processes, and prepare for regulatory scrutiny. Our experience in GCP and PV quality allows us to guide teams in optimizing documentation, streamlining workflows, and resolving safety-related quality issues, all while avoiding bureaucracy. Whether aligning safety practices with GxP expectations or supporting inspection readiness, the goal is always the same: practical improvements that enhance quality where it matters most./p>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-983c0a4c alignfull uagb-is-root-container>div classuagb-container-inner-blocks-wrap>div classwp-block-uagb-advanced-heading uagb-block-a9f8b90a>h2 classuagb-heading-text>Services/h2>/div>div classwp-block-uagb-container uagb-block-95cf4f96>div classwp-block-uagb-container uagb-block-f7aebd32>div classwp-block-uagb-info-box uagb-block-46ff6880 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Clinical Trial Safety Oversight/h3>/div>p classuagb-ifb-desc>Medical review of AE/SAE databr>br>Safety surveillance & emerging risk evaluationbr>br>Narrative quality checks & medical consistency reviewbr>Safety input for DSURs, ASRs, clinical protocols, and study reportsbr>/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#CTOversight target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-3566f895>div classwp-block-uagb-info-box uagb-block-211dc44a uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Medical Monitoring/h3>/div>p classuagb-ifb-desc>Medical oversight of subject eligibility and endpointsbr>br>Clinical plausibility checks & issue escalationbr>br>Review of data listings and safety trendsbr>br>Medical support during start-up, conduct, and close-out/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#MMandCoding target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-8e96ee8e>div classwp-block-uagb-info-box uagb-block-6d6297ae uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>MedDRA Coding & Coding Strategy/h3>/div>p classuagb-ifb-desc>Medical oversight of coding decisionsbr>br>Coding quality review & harmonizationbr>br>Development of coding rules, conventions, and product-specific SMQsbr>br>Expertise in complex oncology, ATMPs, immunology/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#MMandCoding target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-55f77ce2>div classwp-block-uagb-container uagb-block-a8d7f22e>div classwp-block-uagb-info-box uagb-block-3df39cb5 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Medical Data Review/h3>/div>p classuagb-ifb-desc>Comprehensive medical review across safety and efficacybr>br>Detection of inconsistencies or medically implausible databr>br>Database lock readiness & clean-file reviewbr>Close collaboration with data management and biometrics teamsbr>br>/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#MMandCoding target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-494d70cb>div classwp-block-uagb-info-box uagb-block-9c577075 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Operational Case Processing/h3>/div>p classuagb-ifb-desc>Oversight or support for clinical trial & post-marketing ICSRsbr>br>Intake, triage, and quality checksbr>br>Reconciliation (clinical vs safety database)br>br>Workflow streamlining and compliance alignmentbr>br>Support during vendor transitions or system migrations/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#CaseProcessing target_self onclickreturn true; 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classmenu-link>Contact/a>/li>li classpage_item page-item-69 current-menu-item menu-item current-menu-item>a hrefhttps://apoxes.com/ classmenu-link>Home/a>/li>li classpage_item page-item-74 menu-item>a hrefhttps://apoxes.com/services/ classmenu-link>Services/a>/li>/ul>/div>/nav>/div>/div>/div>/div>/div>/header>!-- #masthead -->div idcontent classsite-content>div classast-container>div idprimary classcontent-area primary>main idmain classsite-main>articleclasspost-69 page type-page status-publish ast-article-single idpost-69 itemtypehttps://schema.org/CreativeWork itemscopeitemscope>header classentry-header ast-no-title ast-header-without-markup>/header> !-- .entry-header -->div classentry-content clear data-ast-blocks-layouttrue itemproptext>div classwp-block-uagb-container uagb-block-00c2a0fd alignfull uagb-is-root-container>div classuagb-container-inner-blocks-wrap>div classwp-block-uagb-advanced-heading uagb-block-6b316809>h1 classuagb-heading-text>Expert Clinical Trial Safety, Medical Oversight & Quality Support for Biotech and Pharma/h1>p classuagb-desc-text>Independent consulting focused on safety, medical review, MedDRA coding, data quality, and targeted quality guidance to ensure your clinical trials are medically sound, compliant, and inspection-ready./p>/div>/div>/div>div classwp-block-uagb-container uagb-block-8e76fe38 alignfull uagb-is-root-container>div classwp-block-uagb-image uagb-block-6c51998c wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none>figure classwp-block-uagb-image__figure>img decodingasync data-srcsethttps://apoxes.com/wp-content/uploads/2024/09/g720b07ad64213cb5b97ef5b4ebeb06de645a96845633797898e9ab108cd4e5f82b8c7259f63f34f60c17828bdc40b42e10c5887029264328eb85229a063e5399_1280-1263422-1024x682.jpg 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titleg720b07ad64213cb5b97ef5b4ebeb06de645a96845633797898e9ab108cd4e5f82b8c7259f63f34f60c17828bdc40b42e10c5887029264328eb85229a063e5399_1280-1263422 loadinglazy roleimg/>/noscript>/figure>/div>/div>div classwp-block-uagb-container uagb-block-daf48b7a alignfull uagb-is-root-container>div classuagb-container-inner-blocks-wrap>div classwp-block-uagb-info-box uagb-block-bce261d5 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h2 classuagb-ifb-title>About Us/h2>/div>p classuagb-ifb-desc>At Apoxes, we provide specialized consulting services in clinical trial safety, medical monitoring, MedDRA medical coding, medical data review, and operational case processing, complemented by targeted quality and compliance support.br>Led by Pavol Fuček, MD — former Head of Quality Assurance & Pharmacovigilance and senior medical leader — Apoxes helps biotech and pharmaceutical organizations enhance the safety, medical integrity, and quality of their clinical development programs.br>Our goal is to deliver expert, flexible, and medically driven solutions that strengthen your study execution without unnecessary operational overhead./p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/about-us/ classuagb-infobox-cta-link ast-outline-button target_self relnoopener noreferrer styleborder-width:revert-layer onclickreturn true;>span classuagb-inline-editing>View More/span>/a>/div>/div>/div>/div>/div>div classwp-block-uagb-container uagb-layout-grid uagb-block-5d1ebe48 alignfull uagb-is-root-container>div classwp-block-uagb-image uagb-block-21c6d318 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none>figure classwp-block-uagb-image__figure>img decodingasync 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srchttps://apoxes.com/wp-content/uploads/2024/09/ge805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023-1024x682.jpg altgel capsules, capsules, medicine classuag-image-1229 lazyload width1024 height682 titlege805fce36f7dabf1f1227e3d66302350825d9194277be7db0bcd96e9115f1fbb9cd10342c48be76662f71543cb674072b6a9f7e739da757219a8026b88249055_1280-5834023 loadinglazy roleimg/>/noscript>/figure>/div>div classwp-block-uagb-info-box uagb-block-54072360 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top wp-block-uagb-info-box--has-margin>div classuagb-infobox-margin-wrapper>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h2 classuagb-ifb-title-prefix>Clinical Trial Safety Oversight/h2>p classuagb-ifb-title>Independent medical expertise to safeguard your studies from first patient in to database lock./p>/div>p classuagb-ifb-desc>Clinical trial safety oversight at Apoxes focuses on providing senior medical insight throughout the full lifecycle of a study. With extensive experience in product and clinical trial documents, AE/SAE evaluation, safety surveillance, and medical consistency review, we ensure that safety information is interpreted accurately, emerging risks are identified early, and critical decisions are medically sound. Our approach strengthens the reliability of your safety data, supports regulatory expectations, and enhances the overall execution and integrity of your clinical trial./p>/div>/div>/div>/div>div classwp-block-uagb-container uagb-layout-grid uagb-block-db4be87b alignfull uagb-is-root-container>div classwp-block-uagb-info-box uagb-block-5055817d uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h2 classuagb-ifb-title-prefix>Medical Data Review, MedDRA Coding & Medical Monitoring/h2>p classuagb-ifb-title>Accurate, medically grounded data review to ensure coherent, consistent, and high-quality clinical datasets./p>/div>p classuagb-ifb-desc>We provide comprehensive medical data review encompassing medical monitoring, MedDRA coding oversight, and end-to-end evaluation of clinical data across safety and efficacy domains. The focus is on clinical plausibility, consistency, and meaningful interpretation — ensuring that subject data, coding decisions, narratives, listings, and key endpoints align medically and support the study objectives. This integrated approach improves data quality, reduces rework at database lock, and enables sponsors to rely on clean, coherent, and medically validated datasets for regulatory submission and decision-making./p>/div>/div>div classwp-block-uagb-image uagb-block-78d79ae2 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none>figure classwp-block-uagb-image__figure>img decodingasync data-srcsethttps://apoxes.com/wp-content/uploads/2024/09/g1c669ea4bb5882e03d3bcba39b11bff6b6c1bc168718509fd24d46092c1a5a5a45a429ab51a021049a9ad029baf36085a39f541df3890091e776449f8a8621f7_1280-5146199-1024x750.jpg ,https://apoxes.com/wp-content/uploads/2024/09/g1c669ea4bb5882e03d3bcba39b11bff6b6c1bc168718509fd24d46092c1a5a5a45a429ab51a021049a9ad029baf36085a39f541df3890091e776449f8a8621f7_1280-5146199.jpg 780w, 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data-srchttps://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-683x1024.jpg altA sleek tablet with highlighted text and stylus on a wooden table, indoors. classuag-image-1291 lazyload width683 height1024 titlepexels-photo-5206034-5206034 loadinglazy roleimg/>noscript>img decodingasync srcsethttps://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-683x1024.jpg ,https://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-scaled.jpg 780w, https://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-scaled.jpg 360w sizesauto, (max-width: 480px) 150px srchttps://apoxes.com/wp-content/uploads/2025/12/pexels-photo-5206034-5206034-683x1024.jpg altA sleek tablet with highlighted text and stylus on a wooden table, indoors. classuag-image-1291 lazyload width683 height1024 titlepexels-photo-5206034-5206034 loadinglazy roleimg/>/noscript>/figure>/div>div classwp-block-uagb-info-box uagb-block-d4726e81 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top wp-block-uagb-info-box--has-margin>div classuagb-infobox-margin-wrapper>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h2 classuagb-ifb-title-prefix>Quality Support for Clinical Safety & Compliance/h2>p classuagb-ifb-title>Practical, targeted quality guidance designed to strengthen clinical and safety operations without unnecessary complexity./p>/div>p classuagb-ifb-desc>Apoxes offers focused quality support that complements safety and medical oversight activities, helping sponsors maintain compliance, refine internal processes, and prepare for regulatory scrutiny. Our experience in GCP and PV quality allows us to guide teams in optimizing documentation, streamlining workflows, and resolving safety-related quality issues, all while avoiding bureaucracy. Whether aligning safety practices with GxP expectations or supporting inspection readiness, the goal is always the same: practical improvements that enhance quality where it matters most./p>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-983c0a4c alignfull uagb-is-root-container>div classuagb-container-inner-blocks-wrap>div classwp-block-uagb-advanced-heading uagb-block-a9f8b90a>h2 classuagb-heading-text>Services/h2>/div>div classwp-block-uagb-container uagb-block-95cf4f96>div classwp-block-uagb-container uagb-block-f7aebd32>div classwp-block-uagb-info-box uagb-block-46ff6880 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Clinical Trial Safety Oversight/h3>/div>p classuagb-ifb-desc>Medical review of AE/SAE databr>br>Safety surveillance & emerging risk evaluationbr>br>Narrative quality checks & medical consistency reviewbr>Safety input for DSURs, ASRs, clinical protocols, and study reportsbr>/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#CTOversight target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-3566f895>div classwp-block-uagb-info-box uagb-block-211dc44a uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Medical Monitoring/h3>/div>p classuagb-ifb-desc>Medical oversight of subject eligibility and endpointsbr>br>Clinical plausibility checks & issue escalationbr>br>Review of data listings and safety trendsbr>br>Medical support during start-up, conduct, and close-out/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#MMandCoding target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-8e96ee8e>div classwp-block-uagb-info-box uagb-block-6d6297ae uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>MedDRA Coding & Coding Strategy/h3>/div>p classuagb-ifb-desc>Medical oversight of coding decisionsbr>br>Coding quality review & harmonizationbr>br>Development of coding rules, conventions, and product-specific SMQsbr>br>Expertise in complex oncology, ATMPs, immunology/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#MMandCoding target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-55f77ce2>div classwp-block-uagb-container uagb-block-a8d7f22e>div classwp-block-uagb-info-box uagb-block-3df39cb5 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Medical Data Review/h3>/div>p classuagb-ifb-desc>Comprehensive medical review across safety and efficacybr>br>Detection of inconsistencies or medically implausible databr>br>Database lock readiness & clean-file reviewbr>Close collaboration with data management and biometrics teamsbr>br>/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#MMandCoding target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-494d70cb>div classwp-block-uagb-info-box uagb-block-9c577075 uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Operational Case Processing/h3>/div>p classuagb-ifb-desc>Oversight or support for clinical trial & post-marketing ICSRsbr>br>Intake, triage, and quality checksbr>br>Reconciliation (clinical vs safety database)br>br>Workflow streamlining and compliance alignmentbr>br>Support during vendor transitions or system migrations/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#CaseProcessing target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>div classwp-block-uagb-container uagb-block-d7c4fe31>div classwp-block-uagb-info-box uagb-block-dfe7059c uagb-infobox__content-wrap  uagb-infobox-icon-above-title uagb-infobox-image-valign-top>div classuagb-ifb-content>div classuagb-ifb-title-wrap>h3 classuagb-ifb-title>Quality Support/h3>/div>p classuagb-ifb-desc>Quality guidance for clinical safety and PV activitiesbr>br>Review and optimization of safety–clinical processesbr>br>Inspection readiness (clinical safety / PV)br>br>QMS/quality documentation developmentbr>br>Regulatory communication support (EMA, FDA, MHRA, SUKL)/p>div classuagb-ifb-button-wrapper wp-block-button>a hrefhttps://apoxes.com/services/#Quality target_self onclickreturn true; classuagb-infobox-cta-link relnoopener noreferrer>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 512 512>path dM502.6 278.6l-128 128c-12.51 12.51-32.76 12.49-45.25 0c-12.5-12.5-12.5-32.75 0-45.25L402.8 288H32C14.31 288 0 273.7 0 255.1S14.31 224 32 224h370.8l-73.38-73.38c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l128 128C515.1 245.9 515.1 266.1 502.6 278.6z>/path>/svg>span classuagb-inline-editing>Read More/span>/a>/div>/div>/div>/div>/div>div classwp-block-uagb-buttons uagb-buttons__outer-wrap uagb-btn__default-btn uagb-btn-tablet__default-btn uagb-btn-mobile__default-btn uagb-block-33c6571d>div classuagb-buttons__wrap uagb-buttons-layout-wrap >div classwp-block-uagb-buttons-child uagb-buttons__outer-wrap uagb-block-88024e39 wp-block-button>div classuagb-button__wrapper>a classuagb-buttons-repeater ast-outline-button aria-label styleborder-width:revert-layer hrefhttps://apoxes.com/services/ relfollow noopener target_self rolebutton>div classuagb-button__link>All Services/div>span classuagb-button__icon uagb-button__icon-position-after>svg xmlnshttps://www.w3.org/2000/svg viewBox0 0 448 512 aria-hiddentrue focussablefalse>path dM438.6 278.6l-160 160C272.4 444.9 264.2 448 256 448s-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L338.8 288H32C14.33 288 .0016 273.7 .0016 256S14.33 224 32 224h306.8l-105.4-105.4c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160C451.1 245.9 451.1 266.1 438.6 278.6z>/path>/svg>/span>/a>/div>/div>/div>/div>/div>/div>/div>!-- .entry-content .clear -->/article>!-- #post-## -->/main>!-- #main -->/div>!-- #primary -->/div> !-- ast-container -->/div>!-- #content -->footerclasssite-footer idcolophon itemtypehttps://schema.org/WPFooter itemscopeitemscope itemid#colophon>div classsite-primary-footer-wrap ast-builder-grid-row-container site-footer-focus-item ast-builder-grid-row-3-lheavy ast-builder-grid-row-tablet-3-equal ast-builder-grid-row-mobile-full ast-footer-row-stack ast-footer-row-tablet-stack ast-footer-row-mobile-stack data-sectionsection-primary-footer-builder>div classast-builder-grid-row-container-inner>div classast-builder-footer-grid-columns site-primary-footer-inner-wrap ast-builder-grid-row>div classsite-footer-primary-section-1 site-footer-section site-footer-section-1>aside classfooter-widget-area widget-area site-footer-focus-item footer-widget-area-inner data-sectionsidebar-widgets-footer-widget-1 aria-labelFooter Widget 1				>section idblock-40 classwidget widget_block>h2 classwp-block-heading>strong>Quality . Safety . Solutions/strong>/h2>/section>/aside>/div>div classsite-footer-primary-section-2 site-footer-section site-footer-section-2>aside classfooter-widget-area widget-area site-footer-focus-item footer-widget-area-inner data-sectionsidebar-widgets-footer-widget-3 aria-labelFooter Widget 3		>section idblock-31 classwidget widget_block widget_text>p>Apoxes s.r.o.br>Varšavská 715/36 - Vinohradybr>120 00 Praha 2br>Czech Republicbr>info@apoxes.com/p>/section>/aside>/div>div classsite-footer-primary-section-3 site-footer-section site-footer-section-3>aside classfooter-widget-area widget-area site-footer-focus-item footer-widget-area-inner data-sectionsidebar-widgets-footer-widget-4 aria-labelFooter Widget 4		>section idblock-36 classwidget widget_block widget_text>p>ID: 21190089br>VAT: CZ 21190089br>Limited company registered by the Municipal Court in Praguebr>(C 398021)/p>/section>/aside>/div>/div>/div>/div>div classsite-below-footer-wrap ast-builder-grid-row-container site-footer-focus-item ast-builder-grid-row-full ast-builder-grid-row-tablet-full ast-builder-grid-row-mobile-full ast-footer-row-stack ast-footer-row-tablet-stack ast-footer-row-mobile-stack data-sectionsection-below-footer-builder>div classast-builder-grid-row-container-inner>div classast-builder-footer-grid-columns site-below-footer-inner-wrap ast-builder-grid-row>div classsite-footer-below-section-1 site-footer-section site-footer-section-1>div classast-builder-layout-element ast-flex site-footer-focus-item ast-footer-copyright data-sectionsection-footer-builder>div classast-footer-copyright>p>Copyright 2025 | Apoxes/p>/div>/div>/div>/div>/div>/div>/footer>!-- #colophon -->/div>!-- #page --> script typespeculationrules> {prefetch:{source:document,where:{and:{href_matches:/*},{not:{href_matches:/wp-*.php,/wp-admin/*,/wp-content/uploads/*,/wp-content/*,/wp-content/plugins/*,/wp-content/themes/astra/*,/*\\?(.+)}},{not:{selector_matches:arel~\nofollow\}},{not:{selector_matches:.no-prefetch, .no-prefetch a}}},eagerness:conservative}} /script> script> /(trident|msie)/i.test(navigator.userAgent)&&document.getElementById&&window.addEventListener&&window.addEventListener(hashchange,function(){var t,elocation.hash.substring(1);/^A-z0-9_-+$/.test(e)&&(tdocument.getElementById(e))&&(/^(?:a|select|input|button|textarea)$/i.test(t.tagName)||(t.tabIndex-1),t.focus())},!1); /script> script idastra-theme-js-js-extra> var astra  {break_point:921,isRtl:,is_scroll_to_id:,is_scroll_to_top:,is_header_footer_builder_active:1,responsive_cart_click:flyout};//# sourceURLastra-theme-js-js-extra /script> script defer srchttps://apoxes.com/wp-content/themes/astra/assets/js/minified/frontend.min.js?ver4.8.1 idastra-theme-js-js>/script> script defer srchttps://apoxes.com/wp-content/plugins/sg-cachepress/assets/js/lazysizes.min.js?ver7.7.2 idsiteground-optimizer-lazy-sizes-js-js>/script> script defer srchttps://apoxes.com/wp-includes/js/dist/dom-ready.min.js?verf77871ff7694fffea381 idwp-dom-ready-js>/script> script idstarter-templates-zip-preview-js-extra> var starter_templates_zip_preview  {AstColorPaletteVarPrefix:--ast-global-color-,AstEleColorPaletteVarPrefix:ast-global-color-0,ast-global-color-1,ast-global-color-2,ast-global-color-3,ast-global-color-4,ast-global-color-5,ast-global-color-6,ast-global-color-7,ast-global-color-8};//# sourceURLstarter-templates-zip-preview-js-extra /script> script defer srchttps://apoxes.com/wp-content/uploads/siteground-optimizer-assets/starter-templates-zip-preview.min.js?ver06758d4d807d9d22c6ea idstarter-templates-zip-preview-js>/script> script defer srchttps://apoxes.com/wp-content/plugins/ultimate-addons-for-gutenberg/assets/js/spectra-block-positioning.min.js?ver2.19.14 iduagb-block-positioning-js-js>/script> script defer srchttps://apoxes.com/wp-content/plugins/ultimate-addons-for-gutenberg/assets/js/uagb-button-child.min.js?ver2.19.14 iduagb-button-child-js-js>/script> script defer srchttps://apoxes.com/wp-content/uploads/siteground-optimizer-assets/uag-script-69.min.js?ver1764870722 iduag-script-69-js>/script>/body>/html>

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