Transforming trial designs with innovative statistical methodologies.

Clinical Trial Design & Statistical Consulting

Phase I: Expertise in designing studies to determine Maximum Tolerated Dose (MTD) and Optimal Biological Dose (OBD), including dose-escalation methods and model-based designs.

Phase II & III: Advanced trial designs, including Bayesian design for adaptive trials, integrating Real-World Data (RWD) into trials., Designing trials with multiple endpoints or seamless transitions, and adaptive and seamless trial designs.

Statistical Analysis & Reporting

• Performing detailed statistical analyses to support trial objectives and regulatory submissions.
• Generating comprehensive reports and preparing presentations for Data Safety Monitoring Boards (DSMB) or Independent Data Monitoring Committees (IDMC).

Independent Data Monitoring Committee (IDMC) Services

• Acting as an independent IDMC, providing unbiased oversight to ensure patient safety and trial integrity.

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