Innovative Study Designs
This service covers trial design blueprints, simulation reports and digital twin frameworks that combine new evidence with existing data sources, providing a strong basis for efficient, patient-centred paediatric studies. Innovative designs introduce flexible, efficient approaches such as adaptive, master protocol, and Bayesian trials, improving data quality and ethical standards. They also integrate real-world data (RWD) and in silico evidence (e.g., digital twins, virtual cohorts) to complement traditional research. The service provides high-level methodological consulting to address challenges of small patient populations and ethical considerations.The service delivers consulting reports, trial design proposals, simulation results, guidance documents, contributions to study protocols, and regulatory support materials. Reuse of existing and RWD feeds models and simulations to create synthetic control arms, strengthen predictions, and reduce recruitment needs.
