In healthcare and life sciences, the cost of an evidence failure is not a correction notice — it’s a patient outcome, a regulatory action, or a trial result that can’t be replicated. Augle applies adversarial scrutiny to clinical evidence, trial design, coverage decisions, and drug interaction analyses before they inform a consequential choice.
Clinical evidence passes through layers of review that share a bias: they are conducted by teams who have invested in the research, are familiar with its limitations, and have an interest in the conclusions holding. The external reviewer — a payer’s medical director, a regulatory agency, an HTA committee — has none of these interests and will find the things internal review missed. Augle runs that external review first.
Questions healthcare teams run on Augle
Clinical integrity mode flags retracted studies at Critical severity — the highest level, triggering a mandatory halt. The Guardian’s SVS checks every citation in a clinical evidence base against retraction databases before any agent receives the evidence. A retracted study does not enter the deliberation. It is flagged, and the session cannot proceed until the condition is resolved.
The Methodologist evaluates construct validity — whether the primary endpoint actually measures what the efficacy claim requires. A trial that uses a surrogate endpoint where a clinical outcome endpoint is required by the HTA framework, or a composite endpoint whose components have heterogeneous clinical significance, is Contested regardless of the p-value.
Clinical integrity mode monitors population scope throughout the session. Evidence derived from a trial with narrow inclusion criteria being applied to a broader treatment population, or subgroup analyses being cited as primary evidence, is flagged with the exclusion criteria preserved in the evidence record — not silently accepted.
The Contrarian takes the role of a well-briefed HTA clinical reviewer or payer medical director — surfacing the comparator selection challenge, the indirect comparison methodology objection, the real-world applicability question. Unresolved Strong objections appear verbatim with resolution conditions. These become the dossier preparation agenda.
Each scenario illustrates realistic deliberation behaviour across HTA submission review, coverage decision analysis, and trial design assessment.
“Does our NICE submission dossier for this oncology indication present the clinical evidence in a way that will withstand the Evidence Review Group’s scrutiny, and what are the two or three objections we need to address?”
Both gaps were addressable — but only if they were addressed proactively in the dossier rather than reactively in the clarification round. The ERG’s clarification questions add months to the appraisal timeline. A dossier that anticipates the questions gets a faster decision.
“Is the clinical evidence presented in this prior authorisation request for a GLP-1 receptor agonist sufficient to support coverage for the requested indication, and what are the coverage criteria gaps?”
The retracted real-world evidence study would have remained in the coverage decision record without SVS. The population mismatch would have been identified by the formulary committee — but after a coverage decision had been issued rather than before. Both were caught at the review stage, not after the fact.
“Does our Phase III trial design for this rare disease indication adequately power the primary endpoint, and what are the design decisions most likely to be challenged at the FDA pre-submission meeting?”
The FDA’s recent guidance was published. The design decision predated it. No one had mapped the guidance to the protocol. Walking into the pre-submission meeting with two prepared scenarios — rather than hearing the question for the first time — is the difference between a productive meeting and a protocol redesign.
Upload clinical study reports, systematic reviews, submission dossiers, trial protocols, and coverage decision packages. Clinical integrity mode activates — the Guardian checks every citation against retraction databases, flags retracted clinical studies at Critical severity, monitors population scope, and validates sample size thresholds against claim strength.
The Cartographer classifies every clinical claim as Settled, Contested, or Unknown within the relevant evidence base. The Methodologist evaluates construct validity — whether the endpoint measures what the claim requires, whether the population matches the target, whether subgroup analyses are adequately powered. Confidence bounds are set as hard constraints.
The Contrarian takes the role of a well-briefed HTA clinical reviewer, payer medical director, or FDA reviewer — surfacing the comparator selection challenge, the endpoint appropriateness question, the population scope objection. Unresolved Strong objections appear verbatim with resolution conditions. These become the dossier preparation agenda.
The full session audit trail — SVS verification outcomes, confidence grades per claim, objections raised and their resolution status — is exportable. For regulatory submissions, HTA dossiers, and coverage decisions, this is the record that demonstrates the evidence base was reviewed to the standard the decision requires.
Clinical integrity mode flags retracted studies at Critical severity — the highest level, triggering a session halt. A retracted study in a clinical evidence base is not a data quality issue — it is a fundamental integrity failure. The Guardian’s SVS catches it before it enters the deliberation. It should not reach an HTA committee, a formulary review, or a regulatory submission.
The Contrarian is calibrated to surface the objection an ERG clinical reviewer, a NICE committee, or a payer medical director will raise — comparator selection, endpoint appropriateness, ITC methodology, population scope. These appear verbatim with resolution conditions. A dossier that anticipates and answers these questions proactively gets a faster and more predictable decision.
Every session produces an exportable audit trail with SVS verification outcomes, confidence grades per clinical claim, and every objection raised and its resolution status. For regulatory submissions, HTA dossiers, and formulary decisions subject to review, this record demonstrates that the evidence base was evaluated to a standard consistent with the decision’s stakes.
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