End-to-End Pipeline
Six Stages. Three Modules. One Continuous Workflow.
Every benefit-risk assessment follows the same validated pipeline — from data ingestion through regulatory output. Each stage feeds directly into the next with full traceability.
1. Data Ingestion
Automated ingestion from clinical trial databases, FAERS, EudraVigilance, VigiBase, published literature (PubMed, Embase), and client proprietary data sources. Continuous feed with versioned snapshots.
2. Data Processing
MedDRA coding, deduplication, data harmonization across heterogeneous sources. NLP extraction from unstructured narratives. Standardized output to the AS Profiling Base of 100+ billion data points.
3. Signal Detection
Disproportionality analysis, temporal pattern recognition, and multi-source signal corroboration using proprietary AI models. Continuous monitoring with configurable alert thresholds.
4. Benefit-Risk Analysis
Structured BRAT framework application with effects tables, value trees, and quantitative weighting. Multi-criteria decision analysis (MCDA) with sensitivity analysis and scenario modeling.
5. Decision Intelligence
24 proprietary AI models synthesize evidence into structured benefit-risk conclusions. Comparative effectiveness evaluation, subpopulation analysis, and lifecycle-aware recommendations.
6. Regulatory Outputs
Submission-ready documents: PSUR/PBRER, Risk Management Plans, CTD Module 2.5, HEOR reports, and signal detection summaries. Formatted for FDA, EMA, and PMDA requirements.
Data Intelligence Engine
The foundation of every analysis. The AS Profiling Base aggregates, harmonizes, and maintains 100+ billion data points from every major pharmacovigilance and clinical data source — updated continuously, versioned for reproducibility.
Data points analyzed
Integrated data sources
AS Profiling Base
The largest integrated pharmacovigilance dataset available for benefit-risk analysis. Structured clinical trial data, spontaneous adverse event reports, published literature evidence, and real-world data — in a single, queryable environment with full provenance tracking.
Data Sources
FAERS (FDA), EudraVigilance (EMA), VigiBase (WHO-UMC), PubMed, Embase, ClinicalTrials.gov, client CSR databases, CPRD, Optum, MarketScan, and proprietary real-world evidence feeds. New sources are onboarded within 2 weeks.
Harmonization Engine
Automated MedDRA coding, cross-source deduplication, NLP extraction from unstructured case narratives, and standardized ontology mapping. All transformations are auditable with full data lineage tracking from raw source to analytical output.
BRAT Framework
Full Benefit-Risk Action Team framework implementation with structured decision trees, effects tables, and value trees. Compliant with FDA and EMA guidance on structured benefit-risk assessment methodologies. Transparent visualization of benefit-risk trade-offs for regulatory communication.
Multi-Criteria Decision Analysis (MCDA)
Quantitative benefit-risk evaluation with configurable criteria weighting, stochastic sensitivity analysis, and scenario modeling. Supports swing weighting, SMAA (Stochastic Multi-criteria Acceptability Analysis), and preference-based approaches used by HTAs globally.
24 Proprietary AI Models
Domain-specific models trained on pharmacovigilance and pharmacoepidemiology data — not general-purpose LLMs applied to healthcare. Covers signal detection, causal inference, comparative effectiveness, NLP extraction, risk quantification, and predictive safety modeling.
Decision Intelligence
Where data becomes structured evidence. The Decision Intelligence module applies regulatory-aligned frameworks, quantitative methods, and 24 proprietary AI models to generate defensible benefit-risk conclusions at every stage of the drug lifecycle.
Proprietary AI models
Regulatory-Grade Automated Outputs
Not dashboards. Submission-ready documents formatted for FDA, EMA, and PMDA — generated directly from your analysis with full traceability from data point to regulatory conclusion. 50+ submissions accepted by regulatory authorities.
Regulatory submissions accepted
PSUR / PBRER
Automated Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports with integrated data tables and signal summaries.
Risk Management Plans
EU-GVP Module V compliant RMPs with safety specification, pharmacovigilance plan, and risk minimization measures.
CTD Module 2.5
Clinical Overview for regulatory submission with integrated benefit-risk summary, comparator analysis, and regulatory-aligned conclusions.
HEOR Reports
Value dossiers, HTA submission packages, comparative effectiveness summaries, and payer communication materials.
Signal Detection Reports
Continuous signal monitoring summaries with disproportionality metrics, temporal trends, and recommended actions. Configurable reporting cadence — weekly, monthly, or event-triggered. Full audit trail for regulatory inspection readiness.
Comparison
How ArcaScience Compares
ArcaScience replaces fragmented tooling, manual processes, and consulting-led engagements with one integrated, validated platform.
| Capability | ArcaScience | Manual BRA | CROs | Point Solutions |
|---|---|---|---|---|
| Integrated data-to-output pipeline | Yes — end-to-end | No — Excel, SAS, Word | Partial — siloed deliverables | No — single-stage tools |
| Domain-specific AI models | 24 proprietary models | None | Generic / off-the-shelf | 1-2 task-specific |
| Integrated data points | 100B+ continuously updated | Client data only | Project-scoped | Single-source |
| Time to BRA completion | Weeks | 12-18 months | 6-12 months | N/A — partial output only |
| Regulatory-ready outputs | PSUR, RMP, CTD 2.5, HEOR | Manual Word documents | Consultant-authored | Dashboards / raw data |
| Full lifecycle coverage | Phase I through post-marketing | Per-project scope | Per-engagement scope | Single phase / function |
| 21 CFR Part 11 audit trail | Yes — full traceability | Limited / manual | Varies by CRO | Rarely |
| Consistent methodology | Validated, reproducible | Analyst-dependent | Varies by team | Tool-dependent |
Enterprise Compliance
ArcaScience is validated to FDA 21 CFR Part 11 requirements with full electronic signature support, complete audit trails, and role-based access controls. Data residency options available for EU (GDPR/HDS) and US (HIPAA) regulatory compliance.
Security & Compliance Details →