Our team of highly qualified MDs and PhDs includes expertise in regulatory, clinical, statistics, pharmacometrics, data science, and commercialization. Our people are widely published, internationally prominent thought leaders who collaborate with an extensive network of health professionals from industry, academic institutions, and government bodies.
Design Portfolio
Overview
Since 2020, we have seen a marked increase in both the adoption and sophistication of adaptive trial designs. Innovations are present across therapeutic areas and throughout the development cycle from early dose finding to late-stage confirmatory studies.
Innovative
Design
Design
- Platform Trials
- Combination Therapy
- Adaptive Sequential Bayesian
- External Controls
- Population Enrichment
- Sample Size Re-Estimation
- Group Sequential
- Seamless Phase 2/3
- Adaptive Dose-Finding
- Cohort Expansion
- Bayesian Basket
- Single and Dual Agent Dose Escalation
Recent Innovative Design Projects
Bayesian Dynamic Borrowing Design
Phase 2 - Dermatitis
Adaptive Population enrichment design
Phase 3 - Oncology
Dual endpoints (one continuous, one binary)
Phase 3 - Inflammation
Single arm open label extention; Historical control borrowing plan
Phase 2 - Nephrology
Bayesian SCA + Multiple Endpoints
Phase 3 - Allergy
Biomarker Predictive Model (Sensitivity/Specific study)
Phase 2 - BC Assay
Seamless p2/3 design
Phase 2/3 - Rare Pulmonary
Dose Escalation - TITE BOIN design
Phase 1 - Oncology
Using Early endpoint as surrogate for primary EP
Phase 2/3 - Lupus
Dose Escalation - BLRM design
Phase 1 - Oncology
Design using RWD simulations
Phase 3 - CV
Dose Escalation - BOIN & Dose Expansion
Phase 1/2 - Oncology
Meet the teams contributing to the CDI
Whether for Rx new medicines, medical devices or over the counter (OTC) products, we share your ambition to bring new products to market quickly, efficiently and safely - with the utmost scientific rigor and to the maximum benefit of patients.
Our team members help you craft a bespoke development plan for your asset, optimizing your regulatory, clinical, and market access pathways, by identifying appropriate strategies and using data to support the decision-making process at every stage, from concept to commercialization.
Our team members help you craft a bespoke development plan for your asset, optimizing your regulatory, clinical, and market access pathways, by identifying appropriate strategies and using data to support the decision-making process at every stage, from concept to commercialization.
Who We Are
Our team of highly qualified MDs and PhDs includes expertise in regulatory, clinical, statistics, pharmacometrics, data science, and commercialization. Our people are widely published, internationally prominent thought leaders who collaborate with an extensive network of health professionals from industry, academic institutions, and government bodies.
Featured CDI Contributors
Contact Us
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