January 4, 2015

Clinical Development


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 – impeccable quality, on time, and on budget.

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.

» Planning & Oversight

{T} Phases I-IV

{T} Post-Marketing, Registry, Investigator Initiated, Observational Studies

{T}› Concept Through Submission

{T} Clinical Program & Study Design

{T} Study Operations & Logistics

{T} Monitoring Plan Development

{T} Packaging & Labeling

{T} CRO & Vendor Selection

{T} Gap Analyses

» Execution

{T} Clinical Study Management

{T} Protocol Development

{T} Study Document Design

{T} Feasibility: Country & Site Selection / Trial Placement

{T} Investigator Identification & Selection

{T}› Recruitment, Start-Up, Site Initiation, Maintenance, Monitoring, Database Lock, Close-Out

{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