Our services
Clinical Study Project Management & Support
Coordinated Execution. Controlled Delivery.
We provide structured clinical study project management operational support across feasibility, site activities, monitoring coordination, documentation and study close-out.
Capabilities
CLINICAL STUDY PROJECT MANAGEMENT & SUPPORT
STUDY FEASIBILITY & PLANNING
- Study Feasibility Assessment
- Site Feasibility
- Investigator / Site Identification
- Site Selection
- Study Planning
- Operational Assessment
- Resource Planning
- Timeline Development
- Study Start-Up Planning
SITE START-UP & INITIATION
- Site Qualification Support
- Site Selection Coordination
- Site Initiation Support
- Investigator Coordination
- Essential Document Coordination
- Site Readiness Assessment
- Start-Up Tracking
- Activation Support
STUDY OPERATIONS & COORDINATION
- Study Project Coordination
- Site Coordination
- Investigator Communication
- Sponsor Communication
- Study Timeline Management
- Milestone Tracking
- Meeting Coordination
- Action Tracking
- Study Documentation Management
MONITORING & SITE OVERSIGHT
- Monitoring Coordination
- On-Site Monitoring Support
- Remote Monitoring Support
- Monitoring Visit Tracking
- Site Performance Monitoring
- Follow-Up Activities
- Query Tracking
- Issue Escalation
- Monitoring Documentation Review
PROJECT & STAKEHOLDER MANAGEMENT
- Project Planning
- Stakeholder Coordination
- Vendor Coordination
- Cross-Functional Communication
- Deliverable Tracking
- Risk Tracking
- Issue Management
- Escalation Management
- Project Status Reporting
- Management Reporting
QUALITY & COMPLIANCE OVERSIGHT
- Protocol Compliance Support
- GCP Compliance Support
- Site Documentation Review
- Deviation Tracking
- Corrective Action Follow-Up
- Risk-Based Oversight
- Essential Document Oversight
- Compliance Tracking
- Inspection Readiness Support
PMS & POST-MARKETING STUDY SUPPORT
- PMS Study Planning
- Site Feasibility
- Site Selection
- Study Coordination
- Data / Documentation Review
- Safety Coordination
- Study Progress Monitoring
- Post-Marketing Study Documentation
- Study Report Review
STUDY DOCUMENTATION & REPORTING
- Study Documentation Management
- Site Files
- Study Trackers
- Monitoring Reports
- Visit Documentation
- Study Status Reports
- Progress Reports
- Issue Logs
- Risk Registers
- Study Report Review
- Close-Out Documentation
STUDY CLOSE-OUT
- Site Close-Out Coordination
- Documentation Reconciliation
- Outstanding Action Tracking
- Final Study Documentation
- Site Closure Support
- Archiving Coordination
- Study Completion Reporting
- Lessons Learned
Discuss your clinical study project management & support requirements
Tell us about your study, sites and timelines, and we will propose a coordinated plan.