Precision Medicine

The Power of Precision Medicine

Precision medicine is allowing delivery of the right treatment to the right patient at the right time.

This entails the use of drugs and other interventions that target validated predictive biomarkers. Our experts can help you develop your precision-medicine drug, companion diagnostic/IVD, and the drug-biomarker pair across a variety of therapeutic areas.

Biomarker-Driven Trials

We propose a variety of biomarker-driven trial designs for all phases of clinical development.

Phase 1

Dose-escalation and expansion cohorts, phase 1/2 trials, rule-based, model-based, and model-assisted designs.

Phase 2

Basket, umbrella, platform and strategy trials, with our without randomization, using frequentist or Bayesian methods.

Phase 3

Enrichment, biomarker-stratified, group-sequential, and multiple-arm, multiple-stage trials.

Personalized Medicine to Individualize Treatment Decisions Benefit

Biostatistical Estimation of Net Effects for Individualization of Therapy