FSP 360 Services
Listening and Learning from Patient Voices
Syneos Health
Clinical Operations
• Clinical Monitoring
• Risk-Based Monitoring Enablement
• Centralized Data Review
• Study Start-Up
Site Contracts & Budgets
Site Ethics & Country Regulatory Submission
Site Activation
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Program & Project Management
• Signal Detection & Case Processing
• Expedited & Periodic Reporting
• QPPV Office Consulting & Support
Safety and Pharmacovigilance
• Data Management
• Biostatistics & Programming
Biometrics
• Protocol Design
• Clinical Study Reports & Manuscripts
• Regulatory Submission Documents
Medical Writing
• Global Investigator Payments
• Sunshine Act/Transparency & Cash
Forecast Reporting
• Patient Reimbursement Services
Investigator Payments
• Protocol Registration & Maintenance
• National Registries
• End-to-End Services
Clinical Trial Closure
• Electronic & Paper TMF Management
• Independent TMF Inspection Readiness &
Compliance Team
Trial Master File
CTMS=clinical trial management system; KPI=key performance indicator; LMS=learning management system; QPPV=qualified person responsible for pharmacovigilance; TMF=trial master file
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Program & Project Management
Clinical Operations
Biometrics
Medical
Writing
Investigator Payments
Trial Master File
Clinical Trial Closure
Regulatory
Administrative Services
Program & Project Management
Safety and Pharmacovigilance
Safety and Pharmacovigilance
Biometrics
Medical
Writing
Investigator Payments
Clinical Trial Closure
Regulatory
Administrative Services
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• Pre- and Post-Approval
• Strategy & Intelligence
• Technology
Regulatory
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• LMS Support
• CTMS Admin Support
• KPI/Dashboard Maintenance
Administrative Services
Clinical Operations
Trial Master File