Clinical Trial Management & Operations
Comprehensive clinical trial management from feasibility to study closure for drug studies (Phase I-IV), medical devices, and IIS, including full start-up support.
Project and budget management oversight
- Project planning: Timeline development, resource allocation, and risk assessment
- Budget control: Cost tracking, site payments, and vendor management
- Financial reporting: Real-time budget monitoring and variance analysis
- Change management: Scope modifications, amendment impact, and cost control
Site selection, initiation, and coordination
- Site identification:
Feasibility assessment and investigator qualification - Site initiation:
SIV planning, training delivery, and activation support - Ongoing coordination:
Performance monitoring, communication, and issue resolution - Site management:
Enrollment tracking, query resolution, and relationship maintenance
- Site identification:
Operational supervision and quality control
- Study oversight:
Protocol compliance monitoring and deviation management - Quality assurance:
Internal audits, CAPA implementation, and process improvement - Vendor coordination:
Laboratory management, central services, and third-party oversight - Risk management:
Issue identification, escalation procedures, and mitigation strategies - Medical monitoring and safety oversight:
Safety signal detection, adverse event assessment, and regulatory safety reporting
- Study oversight:
Study milestone tracking and reporting
- Stakeholder reporting:
Regular updates, dashboard creation, and executive summaries - Timeline monitoring:
Critical path tracking and deadline management - Performance metrics:
Enrollment rates, site productivity, and quality indicators - Milestone management:
Go/no-go decisions, phase transitions, and deliverable tracking
- Stakeholder reporting:
IIS support and academic partnerships
- Academic collaboration:
University partnerships and investigator-driven research - Streamlined processes:
Simplified procedures and cost-effective solutions - Research facilitation:
Protocol development, regulatory support, and operational guidance - Publication strategy:
Manuscript development, conference presentations, and dissemination planning
- Academic collaboration:
