Protocol Design and Development
We collaborate with sponsors to design scientifically rigorous protocols that address key research questions. Our approach optimizes study designs to balance scientific objectives with operational feasibility while ensuring regulatory compliance and ethical standards.
Site Selection and Management
Our team identifies and qualifies high-performing research sites with appropriate patient populations. We provide comprehensive site support including training, monitoring, and performance management to ensure protocol adherence and optimal enrollment.
Patient Recruitment and Retention
We develop targeted recruitment strategies based on protocol-specific patient profiles. Our patient-centric approach maximizes enrollment rates while implementing retention programs that minimize dropout rates and maintain study power.
Study Start-up and Regulatory Submissions
We manage all aspects of study initiation including IRB/EC submissions, regulatory applications, and site activation. Our streamlined processes expedite timelines while ensuring complete documentation and compliance with local and regional requirements.
Clinical Monitoring
Our experienced monitors conduct thorough site visits to verify protocol compliance, source data verification, and GCP adherence. We provide risk-based monitoring approaches that focus resources on critical data points while maintaining overall study quality.
Project Management
We provide dedicated project managers who coordinate all trial activities and serve as the central point of contact. Our team implements comprehensive project plans with milestone tracking, risk management, and regular communication to ensure on-time, within-budget delivery.
Vendor Management
We oversee selection and coordination of specialty vendors including central labs, imaging centers, and ePRO providers. Our integrated approach ensures seamless data flow between vendors while maintaining consistent quality standards across service providers.
Study Closeout
We conduct systematic closeout activities including final monitoring visits, query resolution, and documentation completion. Our closeout procedures ensure all regulatory requirements are fulfilled while preparing sites and data for final analysis and reporting.
