{"id":52,"date":"2022-08-30T09:53:59","date_gmt":"2022-08-30T09:53:59","guid":{"rendered":"https:\/\/www.medfocuscro.com\/?page_id=52"},"modified":"2022-08-30T11:23:33","modified_gmt":"2022-08-30T11:23:33","slug":"our-services","status":"publish","type":"page","link":"https:\/\/www.medfocuscro.com\/?page_id=52","title":{"rendered":"Our services"},"content":{"rendered":"\n<p>Having on board experienced physicians, we welcome projects in various <strong>therapeutic areas<\/strong>. <\/p>\n\n\n\n<p>Our team has strong expertise in:<\/p>\n\n\n\n<ul><li>Neurology<\/li><li>Cardiovascular<\/li><li>Oncology<\/li><li>Rheumatology<\/li><li>Haematology<\/li><li>Rare diseases<\/li><li>Pediatric trials<\/li><li>Ophthalmology<\/li><li>Gastroenterology<\/li><li>Dermatology<\/li><li>COVID -19<\/li><\/ul>\n\n\n\n<p>Other therapeutic areas Medfocus CRO has been actively involved in phase II \u2013 IV trials are respiratory, anaemia, renal transplantation, psychiatry, metabolism, autoimmune diseases, chronic infectious diseases, female reproducing system pathologies, etc.<\/p>\n\n\n\n<p><strong>Medfocus CRO implies:<\/strong><\/p>\n\n\n\n<ul><li>Strategic Project Planning<\/li><li>Regulatory documentation submission and approval follow-up<\/li><li>Clinical Trial Management<\/li><li>Access to a regional clinical centres network<\/li><li>Logistical support<\/li><li>Clinical Monitoring in Phase II to IV Clinical Trials<\/li><li>Data Management and Reporting<\/li><li>Continuous Quality Control and Assurance<\/li><li>Compliance with GCP\/ICH and FDA regulations<\/li><li>Project and Sponsor dedicated personnel<\/li><\/ul>\n\n\n\n<p><strong>Project Management<\/strong><\/p>\n\n\n\n<p>Constant control of: recruitment, budget execution, timelines<br>Identify project challenges<br>Implement timely contingency plans in order to maintain the project on the planned<br>development track<br>Ensure local coordination and logistic support in various activities such as:<\/p>\n\n\n\n<ul><li>partnership with selected specialized companies for performance of special laboratory tests, as required by the study protocol<\/li><li>customs clearance procedures for biologic samples export import\/export of any study related materials (medical equipment, laboratory kits)<\/li><li>interface between Sponsor, Investigators and various study vendors such as IVRS companies, couriers, etc.<\/li><\/ul>\n\n\n\n<p><strong>Feasibility Projects<\/strong><\/p>\n\n\n\n<p>Conduct prompt and pertinent feasibility assessments, based on:<\/p>\n\n\n\n<ul><li>documented site experience in clinical research<\/li><li>documented site enrollment potential &#8211; review of patient registries, referral networks, etc<\/li><li>documented site research staff and facilities<\/li><\/ul>\n\n\n\n<p><strong>Regulatory<\/strong><\/p>\n\n\n\n<ul><li>Consultancy provided to Sponsors for required content of the Clinical Trial Application file<\/li><li>Compiling and submitting the Clinical Trial Application file<\/li><li>Communication with Authorities, interface between Sponsor and local Authorities in case of clarifications required for CT Approval<\/li><li>We cover all aspects of Start-up and Regulatory operations, including CA and EC submissions, sites and other vendors (labs, depots etc.) contract negotiation, and the corresponding oversight of those activities.<\/li><li>Our services will be provided by regulatory specialists with more than 15 years experience in the field, and who will guide and assist you with the preparation of the applications, handling of the submission process and liaising with regulatory bodies in order to obtain regulatory approval.<\/li><li>We have extensive experience with the start-up\/regulatory process, not only in EU countries (such as Romania, Bulgaria, Croatia, Poland) but also in other East and Central<\/li><li>European countries (including Serbia, Bosnia, Moldova)<\/li><\/ul>\n\n\n\n<p><strong>Legal Representative in the E.U.<\/strong><\/p>\n\n\n\n<p>If the Sponsor does not have an office or registered address in the EU and they wish to perform clinical trials in the EU they must have a legal representative who is established within the European Union.<br>This provision is mandatory and without a Legal Representative the clinical trial will not be approved by the Regulatory or Ethics authorities.<br>The Legal Representative may be an individual person or a representative of a corporate entity, should be willing to act as the agent of the sponsor in the event of any legal proceedings instituted in the European Economic Area (EEA), e.g. for service of legal documents, and should be established and contactable at an address in the EEA. We have 5-year expertise in representing non-EU Sponsors (from U.S., Canada, Israel)<br>and our legal representative services will be provided to you by experienced staff, trained in clinical trial processes and legislation, and in the EU regulatory environment.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Having on board experienced physicians, we welcome projects in various therapeutic areas. Our team has strong expertise in: Neurology Cardiovascular Oncology Rheumatology Haematology Rare diseases Pediatric trials Ophthalmology Gastroenterology Dermatology COVID -19 Other therapeutic areas Medfocus CRO has been actively involved in phase II \u2013 IV trials are respiratory, anaemia, renal transplantation, psychiatry, metabolism, autoimmune [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.medfocuscro.com\/index.php?rest_route=\/wp\/v2\/pages\/52"}],"collection":[{"href":"https:\/\/www.medfocuscro.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.medfocuscro.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.medfocuscro.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.medfocuscro.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=52"}],"version-history":[{"count":4,"href":"https:\/\/www.medfocuscro.com\/index.php?rest_route=\/wp\/v2\/pages\/52\/revisions"}],"predecessor-version":[{"id":98,"href":"https:\/\/www.medfocuscro.com\/index.php?rest_route=\/wp\/v2\/pages\/52\/revisions\/98"}],"wp:attachment":[{"href":"https:\/\/www.medfocuscro.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=52"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}