Our Services

As a small, lean firm with deep expertise, we can customize and tailor our portfolio of services to exactly what you need at a price that is manageable for your organization. Reach out to us on our "Contact" page to learn more about our services.

Clinical Trial Design

• Protocol development

• Trial simulation & modeling

• Adaptive trial design

• Endpoint selection & validation

• Randomization strategy

Feasibility & Operational Planning

• Patient population feasibility

• Site selection strategy

• Country & regulatory feasibility

• Risk assessment & mitigation planning

Regulatory Consulting

• Regulatory strategy development

• Pre-IND & IND meeting support

• Prepared briefs & coaching for regulatory meetings

• Protocol review for regulatory readiness

Biostatistics & Data Strategy

Decentralized & Hybrid Trial Consulting

Patient-Centric Trial Design

Strategic Development Advisory

Additional Services

• Statistical Analysis Plan (SAP)

• Interim analysis planning

• Sample size calculations & justification

• Bayesian or frequentist models

• Data Monitoring Committee (DMC) charter development

• Remote/virtual trial strategy

• Technology selection

• Protocol adjustments for virtual components

• Patient Advisory Board engagement

• Simplified protocol designs

• Informed consent optimization

• "Go or no-go" decision consulting

• Portfolio prioritization

• Health Economics & Outcomes Research (HEOR) Input

• Fractional/External CMO for startup

• Startup advisory

• Facilitating protocol writing workshops for sponsor teams

• Leading mock regulatory meetings for internal training