From Start-Up Strategy to Study Close
Comprehensive clinical operations support that adapts to your model—CRO partnerships, hybrid approaches, or internal teams.
Whether you're launching your first trial or managing a portfolio, we provide the operational backbone that keeps you moving forward with confidence.
Strategic Guidance, Not Just Oversight.
Collaborative. Transparent. And designed to build your internal capabilities while delivering immediate results.
Discovery & Strategy
Understanding your goals, constraints, and success metrics. We analyze your therapeutic area, regulatory pathway, and operational preferences to design the optimal approach.
Planning & Setup
Building the operational framework, site network, and vendor relationships. We establish the systems and processes that will drive successful execution.
Execution & Oversight
Day-to-day management with strategic representation. We monitor progress, manage relationships, and advocate for your priorities at every decision point.
Optimization & Growth
Continuous improvement and capability building. We identify efficiencies, strengthen processes, and prepare your team for future success.
Foundation for Success
Strategic planning and operational framework development for first-in-human through late-phase trials. We help you build the foundation right from the start.
Protocol refinement and scientific/operational feasibility review
Country and site selection strategy, qualification, and activation support
CRO/vendor RFP development, bid comparison, and selection oversight
Investigator meeting planning and content development
Regulatory strategy guidance (IND support, health authority correspondence)
Startup package development (manuals, plans, charters, templates)
EDC setup and CRF development and review
Site trainings and relationship-driven engagement
Site contract and budget negotiations
TMF establishment and index planning
Study timeline and enrollment modeling
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Execution with Precision
Day-to-day trial execution with the diligence your science deserves. We become an extension of your team, providing oversight that builds confidence.
Site monitoring and support
Data quality assurance
Timeline management
Risk mitigation
Navigate with Confidence
Optimize your outsourcing relationships with strategic oversight that protects your interests. We help you get maximum value from vendor partnerships while maintaining control of your study outcomes.
Vendor selection and contract negotiation support
Contract oversight and deliverable management
Hybrid model optimization and workflow design
Hybrid model optimization and workflow design
Performance monitoring and accountability measures
