Clinical Operations
Services include but not limited to:
- CRO Selection and Oversight
- Key point of contact
- Protocol Development
- IND submissions (from operational perspective)
- Budget planning, forecasting and management
- Development of Project/Study Plans
- Inspection Readiness according to ICH-GCP and other regulatory guidelines
- Site Feasibility and Selection
- Site Training
- Ongoing Site Management
- CRA Oversight/Co-Monitoring
- KOL/Site/Sponsor relationship building
- Budget and Contract negotiations for sites and vendors
- Process improvements
- Metrics/KPI development, oversight and reporting
- NDA/BLA/MAA Filing and inspections (from an operational perspective)
- Coordinate and execute all operational aspects of clinical trials including but not limited to identification and qualification of vendors, contract and budget negotiations, team leadership and management.
Project/Program Management
Services include but not limited to:
- Development of Project Charter and/or Clinical Development Plans
- Strategic leadership and operational/cross-functional planning
- Define Goals, Objectives and Key Responsibilities
- Reporting project status to executive management
- Coordinate and Lead Governance Meetings
- Gant chart/timeline development and management
- Development of process maps
Vendor Management
Services include but not limited to:
- Vendor Selection and Qualification
- Facilitate and Maintain relationships between your organization and your vendors/partners
- Budget and Contract Negotiations
- Vendor set up and project charter development
- Track, measure, report and evaluate vendor performance
- Troubleshoot vendor problems and present to management as required