Two gates. One evidence strategy.
Most founders design their evidence for the regulator and discover the funding gate too late. We connect both from the start.
01 / GENERATE EVIDENCE
In silico trials, mapped from day one
Aesculytics runs in silico trials to produce clinical evidence before a human study is required. A²I™ maps what evidence is needed for both the regulator and the funder, so nothing generated is wasted.
02 / REGULATORY SUBMISSION
Built to satisfy the regulator first
Evidence is designed to satisfy TGA (AU), MHRA (UK), and FDA (US, ASME V&V 40) from the start. In silico evidence is increasingly accepted by these bodies.
03 / REIMBURSEMENT & FUNDING
Identifying evidence gaps that support positive funding recommendations
Identifies where current evidence falls short of MSAC, NICE, PHARMAC, and CMS standards, and maps the specific evidence needed to close each gap — so the funding case is built alongside the clinical effectiveness case, not after it.
Why this matters
Without A²I™ × Aesculytics
- Evidence designed for regulatory approval only — reimbursement requirements are an afterthought
- Expensive redesigns or new studies required post-clearance
- Very expensive in time and funds to run trials
With A²I™ × Aesculytics
- Early-stage technology de-risked computationally — pre-clinical performance metrics secured before resource-intensive human trials begin
- In silico trials generate regulatory-ready evidence in days to weeks — not months to years
- Trial design optimised through simulation — precise sample sizes, subgroup risks identified, endpoints refined before a single patient is enrolled
- Global regulatory bodies increasingly accept computational modelling — FDA (ASME V&V 40), EU MDR, TGA, and MHRA
- Evidence strategy mapped across regulatory and reimbursement requirements simultaneously