Resources

Whitepapers, insights, webinars, and tools to support your benefit-risk strategy. Expert content on BRA methodology, AI in pharma, regulatory guidance, and signal detection.

Explore our latest insights on AI-driven benefit-risk analysis

Featured

BRA
Whitepaper

Quantitative Benefit-Risk Assessment: A Framework for Structured Decision-Making

A comprehensive guide to implementing quantitative benefit-risk frameworks in pharmaceutical development. Covers BRAT, MCDA, value trees, and regulatory alignment with FDA and EMA guidance. Includes case studies and implementation roadmaps.

Dr. Sarah Chen, Chief Scientific Officer 24 min read Feb 2026
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Whitepaper

AI Models for Signal Detection in Pharmacovigilance

How domain-specific AI models outperform traditional disproportionality methods for identifying safety signals in spontaneous adverse event databases.

Dr. Michael Torres 18 min read
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FDA
Blog Post

FDA Benefit-Risk Framework: 2026 Update

Key changes to FDA's benefit-risk assessment guidance for 2026 — including new expectations for quantitative methods and structured decision frameworks.

Emily Rodriguez 8 min read
0:00 22:15 45:00
Webinar

Automating PBRER Generation with Regulatory Compliance

How ArcaScience generates submission-ready PBRER documents in weeks instead of months — with full FDA 21 CFR Part 11 compliance and audit trails.

Dr. Sarah Chen 45 min watch
Regulatory Update

EMA Benefit-Risk Methodology: Updated Templates

EMA releases updated benefit-risk assessment templates with new structured formats for effects tables and value trees. What this means for your submissions.

Regulatory Team 6 min read
MCDA Benefit Risk 0.35 0.25 0.22 0.18
Whitepaper

MCDA in Pharmaceutical Development: A Practical Guide

Multi-criteria decision analysis (MCDA) for benefit-risk assessment — including swing weighting, SMAA, and preference-based approaches used by global HTAs.

Dr. James Liu 22 min read
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Claims EHR FAERS
Blog Post

Real-World Evidence in Signal Detection: Beyond FAERS

How integrating claims databases and EHR data with spontaneous reporting systems improves signal detection accuracy and reduces false positives.

Dr. Priya Patel 12 min read
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Documentation

Platform API Reference

Complete API documentation for integrating ArcaScience with your clinical trial management systems, safety databases, and regulatory submission workflows.

Engineering Team Reference
100 75 50 25
Webinar

HEOR Value Dossiers for HTA Submissions

Building evidence-based value dossiers for NICE, G-BA, and other health technology assessment bodies — with automated comparative effectiveness analysis.

Dr. Anna Kowalski 38 min watch
BRAT Benefits Risks Efficacy Convenience QoL Impact AE Severity AE Frequency Reversibility
Whitepaper

BRAT Framework Implementation Guide

Step-by-step guide to implementing the Benefit-Risk Action Team (BRAT) framework — from value tree construction to effects tables and regulatory communication.

Dr. Sarah Chen 28 min read
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Articles & Insights

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