{"id":75,"date":"2015-01-04T19:48:13","date_gmt":"2015-01-05T00:48:13","guid":{"rendered":"https:\/\/3sixtypharma.com\/?page_id=75"},"modified":"2023-04-09T19:58:24","modified_gmt":"2023-04-09T23:58:24","slug":"clinical-regulatory","status":"publish","type":"page","link":"https:\/\/3sixtypharma.com\/clinical-regulatory\/","title":{"rendered":"Clinical Development"},"content":{"rendered":"

 <\/p>\n

CLINICAL <\/span>PROJECT MANAGEMENT<\/span>
\n{TEXT}<\/span>
\n3Sixty Pharma Solutions offers the benefit of hands-on Clinical Research and Regulatory writing experience across sectors: Sponsors, Sites, and CROs. We know what it takes to get the job done right \u2013 impeccable quality, on time, and on budget.<\/span> <\/span><\/p>\n

From strategy to minute details, we roll up our sleeves to help organizations conduct all aspects of clinical research, create clear, concise and consistent regulatory documents, develop and revise processes and procedures, cultivate sustainable change, and achieve business-critical goals.
\n<\/span><\/p>\n

\n

{T}<\/span>
\n\u00bb Planning & Oversight<\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Phases I-IV<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Post-Marketing, Registry, Investigator Initiated, Observational Studies<\/span><\/p>\n

{T}\u203a\u00a0<\/span><\/span>Concept Through Submission<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Clinical Program & Study Design<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Study Operations & Logistics<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Monitoring Plan Development<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Packaging & Labeling<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0CRO & Vendor Selection<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Gap Analyses<\/span><\/p>\n

{T}<\/span>
\n\u00bb Execution<\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Clinical Study Management<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Protocol Development<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Study Document Design<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Feasibility: Country & Site Selection \/ Trial Placement <\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Investigator Identification & Selection<\/span><\/p>\n

{T}\u203a\u00a0<\/span><\/span>Recruitment, Start-Up, Site Initiation, Maintenance, Monitoring, Database Lock, Close-Out<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Study Rescue & Root Cause Analysis<\/span><\/p>\n

{T}<\/span>\u203a<\/span><\/span> GCPs\/GCP Auditing, Audit Responses<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Investigator Meetings<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Clinical Study Report (CSR) Writing<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0Inspections: Readiness & Issue Resolution<\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0CRO & Vendor Management<\/span><\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

\"\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

  CLINICAL PROJECT MANAGEMENT {TEXT} 3Sixty Pharma Solutions offers the benefit of hands-on Clinical Research and Regulatory writing experience across sectors: Sponsors, Sites, and CROs. We know what it takes to get the job done right \u2013 impeccable quality, on time, and on budget. From strategy to minute details, we roll up our sleeves to[…]<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"class_list":["post-75","page","type-page","status-publish","hentry"],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/P7wLmz-1d","jetpack_likes_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/pages\/75","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/comments?post=75"}],"version-history":[{"count":0,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/pages\/75\/revisions"}],"wp:attachment":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/media?parent=75"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}