{"id":75,"date":"2015-01-04T19:48:13","date_gmt":"2015-01-05T00:48:13","guid":{"rendered":"https:\/\/3sixtypharma.com\/?page_id=75"},"modified":"2025-03-05T12:25:41","modified_gmt":"2025-03-05T17:25:41","slug":"clinical-regulatory","status":"publish","type":"page","link":"https:\/\/3sixtypharma.com\/clinical-regulatory\/","title":{"rendered":"Clinical & Regulatory"},"content":{"rendered":"

 <\/p>\n

3Sixty Pharma Solutions’ Subject-Matter Experts roll up their sleeves <\/span> and offer
\nhands-on support to <\/span><\/span>help you achieve business-critical goals in clinical research,
\nclinical operations, and regulatory affairs<\/span><\/span>. <\/span><\/span><\/p>\n

From high-level strategy to “in-the-weeds” details, w<\/span><\/span>e know what it takes to get
\nthe job done right \u2013 with impeccable quality, on time, and on budget.<\/span>
\n<\/span><\/span><\/p>\n

\n

Clinical Trial<\/span><\/span> Planning & Oversight<\/span><\/span><\/strong><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0<\/span>Phases I-IV<\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0<\/span>Post-Marketing, Registry, Investigator Initiated, Observational Studies<\/span><\/span><\/p>\n

{T}\u203a Study C<\/span><\/span><\/span>oncept Through Dossier Submission<\/span><\/span><\/p>\n

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

{T}\u203a<\/span><\/span>\u00a0<\/span>Study Operations & Logistics<\/span><\/span><\/p>\n

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

{T}\u203a<\/span><\/span> RFP Support<\/span><\/p>\n

{T}\u203a<\/span><\/span> CRO, CDMO, and Vendor Selection\/Management<\/span><\/span><\/p>\n

\n

Clinical Trial Execution<\/span><\/span><\/strong><\/span><\/p>\n

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

{T}\u203a<\/span><\/span>\u00a0<\/span>Clinical Study Management<\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0<\/span>Protocol Development<\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0<\/span>Study Document Design<\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0<\/span>Feasibility: Country & Site Selection \/ Trial Placement <\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0<\/span>Investigator Identification & Selection<\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span>\u00a0<\/span>Study Rescue & Root Cause Analysis<\/span><\/span><\/p>\n

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

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

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

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

{T}\u203a<\/span><\/span>\u00a0<\/span>CRO & Vendor Management<\/span><\/span><\/p>\n

{T}\u203a<\/span><\/span> Gap Analysis and C<\/span>APA Management<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

  3Sixty Pharma Solutions’ Subject-Matter Experts roll up their sleeves and offer hands-on support to help you achieve business-critical goals in clinical research, clinical operations, and regulatory affairs. From high-level strategy to “in-the-weeds” details, we know what it takes to get the job done right \u2013 with impeccable quality, on time, and on budget. Clinical[…]<\/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":16,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/pages\/75\/revisions"}],"predecessor-version":[{"id":2933,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/pages\/75\/revisions\/2933"}],"wp:attachment":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/media?parent=75"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}