Aesculytics
In Silico Clinical Trials & Computational EvidenceAesculytics delivers specialised In Silico Clinical Trials (ISCT) and computational evidence suites for medtech and pharma innovators — integrating real-world epidemiological data, physics-based simulations, and high-performance Julia scientific computing to build virtual patient cohorts and digital twins. Models project real-world device mechanics and physiological responses across diverse populations, providing regulatory-ready evidence within days to weeks instead of months.
Accelerated submissions
De-risk early-stage technology and secure pre-clinical performance metrics before launching resource-intensive human trials.
Regulatory alignment
Global agencies — US FDA (ASME V&V 40), EU MDR notified bodies — increasingly leverage computational modelling to validate safety and clinical evaluation files.
Optimised trial design
For traditional studies, simulations establish precise sample sizes, identify subgroup risks, and refine endpoints to mitigate costly protocol failure.
01
Medical Device & Active Implant Simulation
Biomechanical stress, fluid dynamics, and physiological performance modelling under worst-case parameters.
02
In Silico Protocol Optimization
Virtual cohort testing (N=1,000+) to justify trial endpoints and track disease progression trajectories.
03
Quantitative Risk Assessment
ISO 14971-compliant biological hazard quantification using real-world epidemiological baselines.
04
Pharmacometrics & Combination Products
Mechanistic PK/PD and drug-device interaction modelling for innovative delivery systems.