Submission-Grade MAIC in Pharma: The AbangeLabs QA Architecture (GxP-Aligned, Audit-Ready)

Описание: How do you trust AI-assisted evidence in a regulated pharma workflow? This video explains the quality assurance layers—traceability, review gates, verified extraction, and CLARA reliability scoring.
AbangeLabs builds the Gen-AI powered MAIC Analysis Ecosystem, a secure SaaS platform for pharma market access, HEOR (health economics and outcomes research), and HTA (health technology assessment). This video presents the platform from a different perspective: the quality assurance and reliability architecture designed for regulated evidence generation.
If you’re using generative AI in technical reporting, the key risks are well known: inaccurate extraction, unsupported statements, run-to-run drift, and changes that are not fully traceable. In this walkthrough, we explain the assurance stack built into the AbangeLabs Gen-AI powered MAIC Analysis Ecosystem and how each layer reduces a different failure mode:

Assurance stack covered in this video:
Controlled inputs and provenance: governed target-study inputs, reuse, and traceability

Standardised IPD processing with logged steps: guided data preparation with reproducible processing logs

Results report human review gate: human checkpoint before downstream synthesis

Verified data extraction with HTML authority: authoritative structured source for numbers and tables, cross-checked for accuracy

Master file human review gate: reviewable intermediate master package for transparency

Verified master file as source of truth: consistent derivation of downstream deliverables from a validated master

CLARA reliability seal (non-generative): quantifies section-level consistency across repeated runs so reliability is measured, not assumed

This assurance architecture supports both exploratory decision support and submission-grade production, including regulated-format deliverables such as EU JCA-aligned reporting.

Website: maic.abange.com
Keywords: MAIC, matching-adjusted indirect treatment comparison, HTA, market access, HEOR, comparative effectiveness, time-to-event, Kaplan-Meier pseudo-IPD, evidence synthesis, EU JCA, regulated reporting, GxP aligned, audit ready, QA, reliability, reproducibility, CLARA.