In Silico Clinical Trials & Computational Evidence

Aesculytics

Aesculytics 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.

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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.

Medical Device & Active Implant Simulation

Biomechanical stress, fluid dynamics, and physiological performance modelling under worst-case parameters.

In Silico Protocol Optimization

Virtual cohort testing (N=1,000+) to justify trial endpoints and track disease progression trajectories.

Quantitative Risk Assessment

ISO 14971-compliant biological hazard quantification using real-world epidemiological baselines.

Pharmacometrics & Combination Products

Mechanistic PK/PD and drug-device interaction modelling for innovative delivery systems.