Document CPX-CLAIMS-001Version 1.0Effective 31 Aug 2026Owner security@clinplex.com

Claims registry

Material quantitative performance and evaluation claims published by Clinplex, with their definition, denominator, source and verification date. Only current, verified claims are listed publicly.

Evaluation claims

Exact wordingDefinitionDenominatorSourcePages usedVerifiedStatus
"96% gap-detection accuracy"Proportion of AI-identified gaps confirmed as true gaps by the blinded SME panel. Reported with 95% CI.312-document SME-reviewed subsetDIA 2026 poster P312 (Abstract 115882)Home, Proof2026-06-09Verified
"12.3 regulatory gaps per SOP vs 4.1 under single-framework review" / "3.0× more gaps surfaced"Mean gaps per SOP under multi-framework evaluation vs single-framework manual review of the same SOPs. 3.0× is the ratio 12.3 / 4.1.SOP subset of the corpusDIA 2026 poster P312Home, Proof2026-06-09Verified
"73% less cross-framework assessment time"Reduction in time to complete cross-framework regulatory assessment vs manual single-framework baseline.Timed assessment subsetDIA 2026 poster P312Home, Proof2026-06-09Verified
"κ = 0.87 inter-rater agreement"Cohen's κ for agreement between AI findings and SME-panel adjudication. Reported with 95% CI.312-document subsetDIA 2026 poster P312Home, Proof2026-06-09Verified
"98% critical-tier sensitivity"Proportion of SME-adjudicated Critical findings detected by Clinplex.Critical-tier findings in the 312-document subsetDIA 2026 poster P312Proof2026-06-09Verified
"Evaluated on a 1,035-document regulated corpus"Total documents in the evaluation corpus: SOPs, CAPAs, deviations, audit records, CMC submissions, IQ/OQ/PQ packages, preclinical study reports. "Evaluated," not "validated" — the study was a benchmark evaluation, not a validation under a defined protocol with acceptance criteria.n = 1,035DIA 2026 poster P312Home, Proof, Platform2026-06-09Verified
"Blinded, SME-reviewed 312-document subset" / "7 SME reviewers"Stratified subset independently reviewed by a 7-person Quality and Regulatory panel, blinded to AI output; disputes resolved by consensus.n = 312 of 1,035DIA 2026 poster P312Home, Proof2026-06-09Verified
"273 total gaps"Total unique gaps identified across the full corpus, all document types. Reconciliation: 12.3 per SOP is the SOP-subset mean; 273 is the corpus-wide count — different denominators, both from the same study. This sentence also appears on /proof.Full 1,035-document corpusDIA 2026 poster P312Proof2026-06-09Verified

Product and business claims

Exact wordingDefinitionDenominatorSourcePages usedVerifiedStatus
"Findings come back within 48 hours"Inspection Stress Test turnaround, measured from receipt of the three records to delivery of findings, in business hours.Per engagementOperational commitmentHome, Stress Test, Fits, Platform2026-08-31Verified
"Mutual NDA goes out the same day"NDA dispatched within one business day of request.Per requestOperational commitment (also on /security)Home, Stress Test2026-08-31Verified
"Four lifecycle phases"Discovery & preclinical, quality/manufacturing, clinical operations, CMC/regulatory submissions — as shown in the product.ProductProduct (demo.clinplex.com)Platform2026-08-31Verified
"74% of the 202 CRLs released by FDA involved quality or manufacturing deficiencies"Share of the 202 complete response letters published by FDA citing quality or manufacturing deficiencies, per openFDA data and trade analysis.n = 202 published CRLsopenFDA + trade analysisResources2026-08-31Verified