What we do
Comparative evidence generation for market access.
Head-to-head trial data are often absent. This leaves HTA bodies, payers, and clinical teams with questions your pivotal evidence cannot answer.
The comparative evidence your asset needs
Either your pivotal evidence comes from a single-arm trial, such as in rare disease or oncology.
Or you have randomised data, but not against the treatments patients receive in the market you actually want to enter.
Decision-making stakeholders want to know how your asset compares to a treatment or standard of care that your pivotal trial was never designed to compare against.
We specialise in this exact situation. By generating new evidence from published and real-world data that already exists, we help biotechs build submissions that answer the questions decision-makers are actually asking.
Our methods
Systematic review and meta-analysis
We define the review question with you, then identify and synthesise every piece of relevant evidence. Delivered in weeks, not months, and aligned with PRISMA and Cochrane guidance.
Natural history characterisation
We synthesise evidence on disease progression, outcomes and standard of care. This contextualises efficacy and safety signals, and supports clinical development, orphan drug designation, breakthrough therapy and PRIME applications.
Indirect treatment comparisons
We compare outcomes from your pivotal trial against comparators built from aggregated data in the published literature. Methods include matching-adjusted indirect comparison (MAIC), simulated treatment comparison (STC) and multilevel network meta-regression (ML-NMR).
External control arms
We build external comparators from real-world and historical trial data. Each comparison is designed as a target trial emulation and analysed using doubly robust methods.
EU JCA dossier
We generate the comparative clinical evidence required for each PICO in the JCA assessment scope, including systematic reviews, meta-analyses and indirect comparisons.
HTA dossier
We produce comparative and economic evidence for national HTA submissions, including relative treatment effects, utility values, adverse event rates and transition probabilities for cost-effectiveness models.
In-house workflows, built rigorously to accelerate timelines
We run evidence synthesis through Evidax TRACE™, our AI-augmented, human-in-the-loop workflow, purpose-built for drug development. It is how we deliver a full pooled analysis in weeks instead of months, with rigorous methodology and a complete audit trail behind every decision.
Evidax TRACE™
Regulatory-grade evidence synthesis on an accelerated timeline.
An AI-augmented, human-in-the-loop evidence synthesis workflow, purpose-built for drug development and publicly validated.