{"id":27,"date":"2025-05-20T05:52:46","date_gmt":"2025-05-20T05:52:46","guid":{"rendered":"http:\/\/localhost\/obelysq\/wordpress\/?page_id=27"},"modified":"2025-06-17T11:03:53","modified_gmt":"2025-06-17T11:03:53","slug":"home","status":"publish","type":"page","link":"https:\/\/denys-syebov.com\/","title":{"rendered":"Home"},"content":{"rendered":"<h2>Global Clinical Research &amp; Quality Assurance Expert<\/h2>\n<p>Medical Doctor specialized in internal medicine and oncology, graduated from Odessa State Medical University in 1999.\u00a0Over 25 years of extensive experience in clinical trials spanning clinical operations, medical affairs, and quality assurance across various therapeutic areas at pharma and contract research organizations.\u00a0\u00a0<\/p>\n<p>Independent GxP Consultant (mainly GCP, GDP, GVP) with a proven track records of conducting around 300 on-site and remote audits across USA, Europe and APAC countries.\u00a0People Leader, having managed a multinational Quality Assurance department of staff members across USA, EU and APAC regions.\u00a0\u00a0Lead and Co-Facilitator of 115 GCP regulatory inspections (FDA, EMA, MHRA, PMDA, other country \/ region local Health Authorities) in Europe and APAC (in-house, on-site, remote).\u00a0\u00a0Accomplished presenter at numerous Clinical Research Associates (CRAs) and Investigator Meetings, representing Clinical Quality Assurance.<\/p>\n<p>\t\t\t\t\t<a href=\"#insights\"><br \/>\n\t\t\t\t\t\t\t\t\tOur Insights<br \/>\n\t\t\t\t\t<\/a><br \/>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"387\" height=\"388\" src=\"https:\/\/denys-syebov.com\/wp-content\/uploads\/2025\/05\/image.png\" alt=\"\" srcset=\"https:\/\/denys-syebov.com\/wp-content\/uploads\/2025\/05\/image.png 387w, https:\/\/denys-syebov.com\/wp-content\/uploads\/2025\/05\/image-300x300.png 300w, https:\/\/denys-syebov.com\/wp-content\/uploads\/2025\/05\/image-150x150.png 150w\" sizes=\"auto, (max-width: 387px) 100vw, 387px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/p>\n<h2>Our Services<\/h2>\n<p>\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><\/p>\n<h3>\n                    Clinical Quality Assurance (GxP) services                <\/h3>\n<p>(in-house, on-site and remote) for Pharma, Biotech Companies and Contract Research Organizations<\/p>\n<p>                                                            <a href=\"http:\/\/denys-syebov.com\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><\/p>\n<h3>\n                    GCP Consultancy                <\/h3>\n<p> (QMS concept \/ procedures development, review and implementation, Quality by Design Concept and Risk management, Gap analysis) <\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><\/p>\n<h3>\n                    Investigator Site audits                <\/h3>\n<p>Investigator Site audits<\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><\/p>\n<h3>\n                    GCP, GDP, GVP Vendor audits                <\/h3>\n<p>GCP, GDP, GVP Vendor audits<\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><br \/>\n                    <svg aria-hidden=\"true\" viewBox=\"0 0 576 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M218.17 424.14c-2.95-5.92-8.09-6.52-10.17-6.52s-7.22.59-10.02 6.19l-7.67 15.34c-6.37 12.78-25.03 11.37-29.48-2.09L144 386.59l-10.61 31.88c-5.89 17.66-22.38 29.53-41 29.53H80c-8.84 0-16-7.16-16-16s7.16-16 16-16h12.39c4.83 0 9.11-3.08 10.64-7.66l18.19-54.64c3.3-9.81 12.44-16.41 22.78-16.41s19.48 6.59 22.77 16.41l13.88 41.64c19.75-16.19 54.06-9.7 66 14.16 1.89 3.78 5.49 5.95 9.36 6.26v-82.12l128-127.09V160H248c-13.2 0-24-10.8-24-24V0H24C10.7 0 0 10.7 0 24v464c0 13.3 10.7 24 24 24h336c13.3 0 24-10.7 24-24v-40l-128-.11c-16.12-.31-30.58-9.28-37.83-23.75zM384 121.9c0-6.3-2.5-12.4-7-16.9L279.1 7c-4.5-4.5-10.6-7-17-7H256v128h128v-6.1zm-96 225.06V416h68.99l161.68-162.78-67.88-67.88L288 346.96zm280.54-179.63l-31.87-31.87c-9.94-9.94-26.07-9.94-36.01 0l-27.25 27.25 67.88 67.88 27.25-27.25c9.95-9.94 9.95-26.07 0-36.01z\"><\/path><\/svg><\/p>\n<h3>\n                    Trial Master File                <\/h3>\n<p>Trial Master File<\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><\/p>\n<h3>\n                    CSR Audits                <\/h3>\n<p>CSR Audits<\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><\/p>\n<h3>\n                    Process audits                <\/h3>\n<p>Process audits<\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><br \/>\n                    <svg aria-hidden=\"true\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M377 105L279.1 7c-4.5-4.5-10.6-7-17-7H256v128h128v-6.1c0-6.3-2.5-12.4-7-16.9zm-153 31V0H24C10.7 0 0 10.7 0 24v464c0 13.3 10.7 24 24 24h336c13.3 0 24-10.7 24-24V160H248c-13.2 0-24-10.8-24-24zm64 160v48c0 4.4-3.6 8-8 8h-56v56c0 4.4-3.6 8-8 8h-48c-4.4 0-8-3.6-8-8v-56h-56c-4.4 0-8-3.6-8-8v-48c0-4.4 3.6-8 8-8h56v-56c0-4.4 3.6-8 8-8h48c4.4 0 8 3.6 8 8v56h56c4.4 0 8 3.6 8 8z\"><\/path><\/svg><\/p>\n<h3>\n                    Protocol audits\u00a0                <\/h3>\n<p>Protocol audits\u00a0<\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><br \/>\n                    <svg aria-hidden=\"true\" viewBox=\"0 0 640 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M232 224h56v56a8 8 0 0 0 8 8h48a8 8 0 0 0 8-8v-56h56a8 8 0 0 0 8-8v-48a8 8 0 0 0-8-8h-56v-56a8 8 0 0 0-8-8h-48a8 8 0 0 0-8 8v56h-56a8 8 0 0 0-8 8v48a8 8 0 0 0 8 8zM576 48a48.14 48.14 0 0 0-48-48H112a48.14 48.14 0 0 0-48 48v336h512zm-64 272H128V64h384zm112 96H381.54c-.74 19.81-14.71 32-32.74 32H288c-18.69 0-33-17.47-32.77-32H16a16 16 0 0 0-16 16v16a64.19 64.19 0 0 0 64 64h512a64.19 64.19 0 0 0 64-64v-16a16 16 0 0 0-16-16z\"><\/path><\/svg><\/p>\n<h3>\n                    MDD \/ MDR audits                <\/h3>\n<p>MDD \/ MDR audits<\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><br \/>\n                    <svg aria-hidden=\"true\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM192 40c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm121.2 231.8l-143 141.8c-4.7 4.7-12.3 4.6-17-.1l-82.6-83.3c-4.7-4.7-4.6-12.3.1-17L99.1 285c4.7-4.7 12.3-4.6 17 .1l46 46.4 106-105.2c4.7-4.7 12.3-4.6 17 .1l28.2 28.4c4.7 4.8 4.6 12.3-.1 17z\"><\/path><\/svg><\/p>\n<h3>\n                    GCP Regulatory Inspections preparation and follow-up                <\/h3>\n<p>GCP Regulatory Inspections preparation and follow-up <\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><br \/>\n\t\t\t\t\t        <!-- link opening --><br \/>\n                <!-- end link opening --><br \/>\n                    <svg aria-hidden=\"true\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M352 96c0-53.02-42.98-96-96-96s-96 42.98-96 96 42.98 96 96 96 96-42.98 96-96zM233.59 241.1c-59.33-36.32-155.43-46.3-203.79-49.05C13.55 191.13 0 203.51 0 219.14v222.8c0 14.33 11.59 26.28 26.49 27.05 43.66 2.29 131.99 10.68 193.04 41.43 9.37 4.72 20.48-1.71 20.48-11.87V252.56c-.01-4.67-2.32-8.95-6.42-11.46zm248.61-49.05c-48.35 2.74-144.46 12.73-203.78 49.05-4.1 2.51-6.41 6.96-6.41 11.63v245.79c0 10.19 11.14 16.63 20.54 11.9 61.04-30.72 149.32-39.11 192.97-41.4 14.9-.78 26.49-12.73 26.49-27.06V219.14c-.01-15.63-13.56-28.01-29.81-27.09z\"><\/path><\/svg><\/p>\n<h3>\n                    Inspection Readiness                <\/h3>\n<p>Inspection Readiness<\/p>\n<p>                                                            <a href=\"#\"><br \/>\n                                                                                                                    <\/a><\/p>\n<h2>Send us a Message<\/h2>\n<p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\">\n<ul><\/ul>\n<form action=\"\/wp-admin\/admin-ajax.php#wpcf7-f497-o1\" method=\"post\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<input type=\"hidden\" name=\"_wpcf7\" value=\"497\" \/><br \/>\n<input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.0.6\" \/><br \/>\n<input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><br \/>\n<input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f497-o1\" \/><br \/>\n<input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><br \/>\n<input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><\/p>\n<p><label><br \/>\n<input size=\"40\" maxlength=\"400\" aria-required=\"true\" aria-invalid=\"false\" value=\"Your Name\" type=\"text\" name=\"your-name\" \/><br \/>\n<\/label>\n<\/p>\n<p><label><br \/>\n<input size=\"40\" maxlength=\"400\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Your Company\" value=\"\" type=\"text\" name=\"your-company\" \/><br \/>\n<\/label>\n<\/p>\n<p><label><br \/>\n<input size=\"40\" maxlength=\"400\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Your Email\" value=\"\" type=\"email\" name=\"your-email\" \/><br \/>\n<\/label>\n<\/p>\n<p><label><br \/>\n<input size=\"40\" maxlength=\"400\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Your Phone Number\" value=\"\" type=\"tel\" name=\"your-phone\" \/><br \/>\n<\/label>\n<\/p>\n<p><label><br \/>\n<textarea cols=\"40\" rows=\"10\" maxlength=\"2000\" aria-invalid=\"false\" placeholder=\"Message\" name=\"your-message\"><\/textarea><br \/>\n<\/label>\n<\/p>\n<p><input type=\"submit\" value=\"Send\" \/>\n<\/p>\n<\/form>\n","protected":false},"excerpt":{"rendered":"<p>Global Clinical Research &amp; Quality Assurance Expert Medical Doctor specialized in internal medicine and oncology, graduated from Odessa State Medical [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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