{"id":184,"date":"2021-07-03T02:13:37","date_gmt":"2021-07-03T00:13:37","guid":{"rendered":"https:\/\/www.slsc.ch\/slsc\/?page_id=184"},"modified":"2021-07-03T10:48:22","modified_gmt":"2021-07-03T08:48:22","slug":"clinical-safety-medical-monitoring-services","status":"publish","type":"page","link":"https:\/\/www.slsc.ch\/slsc\/index.php\/clinical-safety-medical-monitoring-services\/","title":{"rendered":"Clinical Safety \/ Medical Monitoring Services"},"content":{"rendered":"\n<p>SLSC can support you with developing the following documents:<\/p>\n\n\n\n<ul><li>Medical Safety Assessments of clinical safety topics<\/li><li>Medical impact assessments (MIA)<\/li><li>Development safety update reports (DSUR)<\/li><li>RSI section of the Investigator\u2019s brochure (IB)<\/li><li>Guidance to investigators section of the IB<\/li><li>ADR sections of the USPI\/SmpC<\/li><li>Periodic benefit-risk evaluation reports (PBRER)<\/li><li>Answers to HA questions<\/li><\/ul>\n\n\n\n<p>SLSC can support you with the review of:<\/p>\n\n\n\n<ul><li>Blinded and un-blinded aggregated clinical data in ongoing studies<\/li><li>Tables, listings, and figures of completed studies<\/li><li>Patient narratives<\/li><li>Serious and non-serious adverse events<\/li><\/ul>\n\n\n\n<p>SLSC can support you with the organisation of:<\/p>\n\n\n\n<ul><li>Scientific advisory boards<\/li><li>Independent safety monitoring boards<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>SLSC can support you with developing the following documents: Medical Safety Assessments of clinical safety topics Medical impact assessments (MIA) Development safety update reports (DSUR) RSI section of the Investigator\u2019s brochure (IB) Guidance to investigators section of the IB ADR [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"_links":{"self":[{"href":"https:\/\/www.slsc.ch\/slsc\/index.php\/wp-json\/wp\/v2\/pages\/184"}],"collection":[{"href":"https:\/\/www.slsc.ch\/slsc\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.slsc.ch\/slsc\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.slsc.ch\/slsc\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.slsc.ch\/slsc\/index.php\/wp-json\/wp\/v2\/comments?post=184"}],"version-history":[{"count":2,"href":"https:\/\/www.slsc.ch\/slsc\/index.php\/wp-json\/wp\/v2\/pages\/184\/revisions"}],"predecessor-version":[{"id":202,"href":"https:\/\/www.slsc.ch\/slsc\/index.php\/wp-json\/wp\/v2\/pages\/184\/revisions\/202"}],"wp:attachment":[{"href":"https:\/\/www.slsc.ch\/slsc\/index.php\/wp-json\/wp\/v2\/media?parent=184"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}