Clinical Services – Summary
CRO Selection & Evaluation
- Identification, assessment, and comparison of qualified CRO partners
- Support with RFI/RFP development and technical capability assessments
Budget Review & Negotiation with CROs
- Detailed cost analysis of CRO proposals
- Negotiation of budgets, assumptions, and payment schedules to ensure value and transparency
Bid Defense Preparation & Participation
- Development of sponsor questions and evaluation criteria
- Active participation in bid-defense meetings to ensure alignment on scope, timelines, and quality expectations
Global Site Selection
- Strategic identification and assessment of high-performing international study sites
- Review of feasibility data, patient access, and country-specific requirements
Oversight of Site Management & Monitoring
- Continuous governance of CRO site management and CRA activities
- Review of monitoring reports, issue escalation, KPIs, and risk-based monitoring performance
Sponsor Oversight Visits
- On-site or remote visits to verify GCP compliance, protocol adherence, and data quality
- Direct engagement with sites to ensure operational excellence and early issue detection
Training & Mentorship
- Study-specific and GCP-compliant training for teams and investigators
- Mentorship of clinical operations staff to buildinternal capability
Regulatory & Ethics Support
- Guidance on IND/CTA preparation, submissions, and responses
- Coordination with ethics committees and regulatory bodies across regions
Sponsor Oversight Visits
- On-site or remote visits to verify GCP compliance, protocol adherence, and data quality
- Direct engagement with sites to ensure operational excellence and early issue detection
