Design your pivotal trial for the payer.
Not just the regulator.
A²I™'s six-stage engine maps the payer-facing assumptions built into your trial design — endpoints, comparators, equity evidence — against 26 named MSAC/NICE/PHARMAC rejection patterns, before you lock it. Aesculytics stress-tests those choices in silico, so you find out now whether they'll satisfy MSAC — and later NICE and PHARMAC — not after a trial that only satisfied the FDA or TGA. (For reference, we also maintain a small FDA evidence-pattern corpus — not scored here, since FDA answers a different question and is already well served by dedicated regulatory-affairs tools.)
This is early. We're not selling a finished product — we're comparing notes with a handful of device teams before we build further.
Two disciplines that don't usually sit in the same room.
One reads committees. One breaks assumptions before committees do. Device teams usually only get one of these — not both.
A²I™ — Assumption Intelligence
The same six-stage methodology already live across our platform for both pharma and device funding: Assumption Mapping, HTA Pattern Matching against a structured MSAC / NICE / PHARMAC device corpus (26 named rejection patterns, M01–M10, N01–N10, P01–P06), Claim Weight Scoring, Evidence Certainty Rating, a non-overridable Equity Gate, and a final Evidence Claim Strength (ECS) Report. On the pharma side, the equivalent corpus is 158 real PHARMAC/PTAC funding decisions. Run the live tool →
Aesculytics
Simulates how a proposed trial's endpoints and comparators hold up once a committee starts asking "what if" — sensitivity analysis, subgroup variation, and the design choices that quietly decide whether the resulting data survives payer scrutiny, run before a single patient is enrolled.
One process, three deliverables.
Run before submission, not after rejection.
Assumption map, pattern match, claim weighting
Stage 01 extracts your evidence assumptions from a structured device intake. Stage 02 matches them against 26 named MSAC/NICE/PHARMAC rejection patterns (e.g. M01 single-arm design, N02 no QALY model, P03 absent Māori/Pacific equity evidence). Stage 03 scores which assumptions are highest-dependency, lowest-evidence — your real failure surface. See the full pattern corpus →
Certainty rating, equity gate, in silico stress test
Stage 04 rates evidence certainty against named MSAC/NICE thresholds. Stage 05 is a non-overridable equity gate — absent equity evidence hard-caps the score at 2.5, full stop. Aesculytics then runs committee-style sensitivity and scenario analysis on the claims flagged highest-risk, before a single patient is enrolled.
ECS Report — Evidence Claim Strength
One report, delivered before you lock your protocol: a 1–5 ECS score, severity-tagged gaps (CRITICAL / MAJOR / MINOR) each citing the exact pattern ID they fail against, priority remedial actions, and where Aesculytics in silico modelling can substitute for a traditional study. Run the live six-stage tool →
How this plays out for a real submission shape.
Hypothetical company, typical pattern. Built to show the mechanism, not a claimed result.
Corvalen Health — ambulatory cardiac monitoring patch
Class IIb wearable, finalising its pivotal trial protocol ahead of enrollment. Trial designed to satisfy the FDA. Not yet designed to satisfy a payer.
The protocol was regulator-ready, not payer-ready
Corvalen's draft protocol powered for FDA-required safety and efficacy endpoints, but matched two HIGH-relevance patterns: M02 (no active comparator against the Australian standard-of-care Holter-monitor pathway) and M07 (equity evidence absent for the over-75 subgroup MSAC weighs first).
The equity gate would have hard-capped the score
M07 alone triggers the non-overridable equity gate — capping the Evidence Claim Strength score at 2.5 regardless of how strong the rest of the evidence was. Aesculytics modelling confirmed the missing comparator arm and subgroup would leave the completed trial unable to answer either point after enrollment.
Two amendments, one trial
The joint ECS report specified the comparator arm (closing M02) and the over-75 subgroup power calculation (closing M07 and clearing the equity gate) to add to the protocol before enrollment — changes that would have required a second trial to fix afterward.
Small team, two lanes.
This collaboration is early-stage and hands-on — you'd be working directly with us, not an account team.
Alia Mahgoub
Founder, A²I™Alia Mahgoub is a Medical Doctor and senior Medical Affairs leader with over a decade of experience leading biologics and vaccine launches across emerging and established markets. She holds an MPH from the University of Edinburgh, an MBChB from the University of Pretoria, and a Postgraduate Diploma in Medicines Development from Stellenbosch University. Through Ascentra Medical, she applies clinical, public health, and strategic expertise to lead Medical Affairs teams through the most critical phases of the product lifecycle.
Arindam Bose
AesculyticsDr. Arindam Bose is the Founder and Principal Consultant at Aesculytics Limited, bridging the gap between clinical medicine, advanced epidemiology, and health technology. As a medical doctor and epidemiologist, he specializes in evidence-based modeling, clinical and epidemiological simulations, and data-driven evaluations for drugs and medical devices. He provides expert research and regulatory strategy to guide healthcare innovations seamlessly from early-stage development to market regulation.
Not a pitch. A comparison of notes.
If you're finalising a pivotal trial protocol and want a second, more adversarial read on whether it'll satisfy a payer as well as a regulator, we'd like fifteen minutes — informal, no deck required on your side.
Set up a call