{"id":4,"date":"2011-04-30T11:30:57","date_gmt":"2011-04-30T11:30:57","guid":{"rendered":"http:\/\/www.phi-medics.co.uk\/?page_id=4"},"modified":"2018-11-14T19:33:39","modified_gmt":"2018-11-14T19:33:39","slug":"clinical-research-development","status":"publish","type":"page","link":"https:\/\/www.phi-medics.co.uk\/?page_id=4","title":{"rendered":"Clinical Research &#038; Development"},"content":{"rendered":"<h2>From Phase I to marketing authorisation application<\/h2>\n<div style=\"float: left; width: 46%;\">\n<h3><span style=\"color: #008080;\">Clinical Development<\/span><\/h3>\n<ul>\n<li>Medical and scientific strategy for:\n<ul>\n<li>Drug development plans<\/li>\n<li>Design and conduct of clinical trials<\/li>\n<\/ul>\n<\/li>\n<li>Write and review\n<ul>\n<li>Protocols<\/li>\n<li>Informed consents<\/li>\n<li>Safety narratives<\/li>\n<li>Clinical trial reports<\/li>\n<li>Investigator brochures<\/li>\n<li>Annual reports and study updates<\/li>\n<\/ul>\n<\/li>\n<li>Organise or represent customer at:\n<ul>\n<li>Steering committee meetings<\/li>\n<li>Data and safety monitoring boards<\/li>\n<li>Investigator meetings<\/li>\n<\/ul>\n<\/li>\n<li>Clinical trial management and conduct\n<ul>\n<li>Provide cover as Medical Monitor<\/li>\n<li>Investigators and Sites Identification<\/li>\n<li>Investigators Training and Support<\/li>\n<li>Study recruitment optimisation<\/li>\n<li>Review of adverse events and safety monitoring<\/li>\n<\/ul>\n<\/li>\n<li>Medical data review and review of coding<\/li>\n<\/ul>\n<\/div>\n<div style=\"float: right; width: 46%;\">\n<h3><span style=\"color: #008080;\">Regulatory Affairs<\/span><\/h3>\n<ul>\n<li>Summaries of Efficacy and Safety, Clinical Overviews<\/li>\n<li>Health Authority Briefing packages<\/li>\n<li>Orphan Drug Applications<\/li>\n<li>PIPs<\/li>\n<li>Clinical Trial Applications<\/li>\n<li>Core Data Sheets, Target Labelling and Patient Information Leaflets<\/li>\n<\/ul>\n<\/div>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>From Phase I to marketing authorisation application Clinical Development Medical and scientific strategy for: Drug development plans Design and conduct of clinical trials Write and review Protocols Informed consents Safety narratives Clinical trial reports Investigator brochures Annual reports and study updates Organise or represent customer at: Steering committee meetings Data and safety monitoring boards Investigator &hellip; <a href=\"https:\/\/www.phi-medics.co.uk\/?page_id=4\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Clinical Research &#038; Development<\/span> <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":73,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=\/wp\/v2\/pages\/4","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4"}],"version-history":[{"count":19,"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=\/wp\/v2\/pages\/4\/revisions"}],"predecessor-version":[{"id":186,"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=\/wp\/v2\/pages\/4\/revisions\/186"}],"up":[{"embeddable":true,"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=\/wp\/v2\/pages\/73"}],"wp:attachment":[{"href":"https:\/\/www.phi-medics.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}