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 – with impeccable quality, on time, and on budget.
Clinical Trial Planning & Oversight
{T}› Phases I-IV
{T}› Post-Marketing, Registry, Investigator Initiated, Observational Studies
{T}› Study Concept Through Dossier Submission
{T}› Clinical Program & Study Design
{T}› Study Operations & Logistics
{T}› Monitoring Plan Development
{T}› RFP Support
{T}› CRO, CDMO, and Vendor Selection/Management
Clinical Trial Execution
{T}› Recruitment, Start-Up, Initiation, Maintenance, Monitoring, Database Lock, Close-Out
{T}› Clinical Study Management
{T}› Protocol Development
{T}› Study Document Design
{T}› Feasibility: Country & Site Selection / Trial Placement
{T}› Investigator Identification & Selection
{T}› Study Rescue & Root Cause Analysis
{T}› GCPs/GCP Auditing, Audit Responses
{T}› Investigator Meetings
{T}› Clinical Study Report (CSR) Writing
{T}› Inspections: Readiness & Issue Resolution
{T}› CRO & Vendor Management
{T}› Gap Analysis and CAPA Management