Manual Process
Fragmented data sources, Excel-based analysis, manual document authoring, multiple rounds of QC, consultant dependencies.
ArcaScience
Integrated pipeline from data ingestion to regulatory submission with full traceability, continuous validation, and automated outputs.
The Six-Stage Pipeline
Every Benefit-Risk Assessment Follows the Same Validated Process
From defining the clinical question through generating submission-ready regulatory documents — each stage feeds directly into the next with complete data lineage and audit trail.
Clinical Framing
Define the benefit-risk question: indication, comparator, patient population, time horizon. Map regulatory requirements to analysis plan. Establish value tree and effects table structure.
Key Outputs
- Regulatory alignment checklist (FDA/EMA/PMDA)
- Decision framework configuration (BRAT, MCDA, or custom)
- Effects table template with pre-mapped endpoints
- Comparator and subpopulation specifications
- Analysis plan version-controlled for audit trail
Data Intelligence Engine
24 proprietary AI models extract, classify, and detect signals from AS Profiling Base 100b® — 100+ billion data points spanning clinical trials, spontaneous reporting databases, electronic health records, published literature, and regulatory submissions.
Data Sources
FAERS, EudraVigilance, VigiBase, ClinicalTrials.gov, PubMed, Embase, client CSR databases, RWE feeds
Data Volume
100B+ data points continuously updated, versioned snapshots for reproducibility
Harmonization
MedDRA coding, deduplication, standardization across heterogeneous sources
AI Processing
NLP for unstructured text (case narratives, literature, regulatory documents). Entity recognition for drugs, adverse events, patient characteristics. Pharmacovigilance-specific classifiers supporting MedDRA coding and causality assessment.
AI Model Categories Applied
NLP Models (6)
Text extraction, entity recognition, classification, sentiment analysis, summarization, translation
Validation Models (6)
Consistency checks, bias detection, completeness scoring, confidence calibration
Strategic Analysis
Quantitative benefit-risk frameworks including MCDA and weighted effects tables. Sensitivity analysis and scenario modeling. Subpopulation-level and comparator-level assessment.
BRAT Framework
Structured value trees and effects tables aligned with FDA/EMA guidance
MCDA
Quantitative weighting with SMAA and swing weighting methodologies
Scenario Modeling
Sensitivity analysis, comparator trade-offs, subpopulation stratification
Decision Intelligence
Interactive visualizations: effects tables, forest plots, value trees. Scenario comparison and trade-off analysis. Complete audit trail for every analytical decision, compliant with 21 CFR Part 11.
Interactive Decision Tools
- Effects tables with real-time comparator switching
- Forest plots with confidence intervals and subpopulation filters
- Value trees with adjustable criteria weighting
- Scenario comparison dashboard with side-by-side analysis
- Complete audit trail with timestamp, user, and rationale for every decision
Automated Outputs
Regulatory documents generated directly from analysis: PSUR/PBRER (ICH E2C(R2)), RMP (EMA GVP Module V), CTD Module 2.5 (ICH M4E), HEOR reports.
PSUR / PBRER
ICH E2C(R2) aligned with automated interval and cumulative data integration
Risk Management Plans
EMA GVP Module V format with safety spec, PV plan, risk minimization
CTD Module 2.5
ICH M4E structure, NDA/BLA/MAA ready with benefit-risk conclusions
HEOR Reports
Value dossiers for NICE, G-BA, HAS, CADTH, PBAC with comparative effectiveness
Time to Completion
From 12-16 Weeks to 2-5 Days
Each stage builds on the previous with no handoffs, no data re-entry, and no waiting for external consultants.
Stage 1-2
Clinical framing and data intelligence configuration
Stage 3-4
AI processing and strategic analysis execution
Stage 5-6
Decision intelligence review and automated output generation
Total Time: ArcaScience
vs 12-16 weeks manual | 83% time reduction