Validated Intelligence for Biomedical Decisions
Pre-built, scientifically validated evidence packs that deliver regulator-ready outputs for drug development, clinical strategy, and regulatory decision-making -- in minutes, not months.
What is an Evidence Pack?
Evidence Packs are modular, validated AI intelligence products. Each one encodes the domain expertise, evidence sources, and analytical workflows needed to answer a specific class of biomedical question with traceable, auditable outputs.
Curated Evidence Bundles
Each pack is a pre-validated collection of evidence sources, analytical workflows, and output schemas purpose-built for a specific biomedical question.
Multi-Agent Intelligence
Specialized AI agents work in orchestrated sequence -- each with domain expertise, defined evidence sources, and calibrated confidence thresholds.
Regulator-Ready Outputs
Every deliverable includes full citation provenance, confidence scoring, and audit trails that meet the documentation standards expected by regulators.
Minutes, Not Months
Evidence synthesis that previously required weeks of literature review and expert consultation is delivered in minutes with traceable methodology.
Why Generic AI Isn't Enough
General-purpose language models were not designed for the evidentiary standards of drug development. BrewBio Evidence Packs close the gap between AI capability and regulatory expectation.
Generic AI hallucinates citations
Every claim is grounded in retrievable, verifiable source material with DOI or database identifiers.
Chat outputs lack structure
Packs produce structured deliverables: tables, risk matrices, regulatory mappings, and formatted dossier sections.
No confidence calibration
Each assertion carries a calibrated confidence score derived from source quality, concordance, and recency.
One-size-fits-all prompts
Purpose-built packs encode domain expertise, regulatory context, and therapeutic area nuance that general models lack.
No audit trail
Complete provenance chain from raw evidence to final output, including agent reasoning traces and source retrieval logs.
Therapeutic Areas
Evidence Packs are organized by therapeutic domain, each curated by subject-matter experts with deep regulatory and clinical development experience.
Oncology
Trial design, dose optimization, biomarker-driven patient selection, and regulatory strategy for solid tumors and hematologic malignancies.
8 packsRegulatory Strategy
IND/NDA/BLA filing strategy, breakthrough therapy designation support, and global regulatory pathway analysis.
6 packsBiomarker & Translational
Biomarker discovery, analytical validation, clinical utility assessment, and companion diagnostic development evidence.
5 packsCMC & Quality
Excipient justification, manufacturing process validation, stability study design, and quality-by-design intelligence.
4 packsCompetitive Intelligence
Pipeline monitoring, clinical trial benchmarking, patent landscape analysis, and market positioning evidence.
3 packsFeatured Evidence Packs
Our most-requested packs, each validated against published literature, regulatory guidance, and expert review.
Oncology Trial Design Pack
Evidence-grounded protocol design for solid tumor and hematologic malignancy trials.
Synthesizes historical trial data, regulatory precedent, and biomarker stratification evidence to generate protocol design recommendations aligned with current FDA guidance.
Dose Optimization Pack
Model-informed dosing strategies backed by PK/PD evidence.
Aggregates exposure-response relationships, toxicity profiles, and dose-finding study outcomes to recommend optimal dose selection and schedule justification.
FDA IND Strategy Pack
Comprehensive IND-enabling intelligence from pre-clinical to first-in-human.
Analyzes FDA guidance documents, recent IND approvals, clinical hold patterns, and CMC expectations to deliver a risk-adjusted IND filing strategy.
Biomarker Validation Pack
Analytical and clinical validation evidence for companion diagnostics.
Evaluates biomarker sensitivity, specificity, and predictive value across published datasets and regulatory submissions to support CDx development.
Excipient Justification Pack
Regulatory-ready excipient safety and precedent analysis.
Cross-references IIG database entries, toxicological data, and approved product formulations to build evidence-based excipient justification dossiers.
Competitive Landscape Pack
Real-time pipeline intelligence with clinical and commercial context.
Monitors clinical trial registries, SEC filings, conference abstracts, and patent databases to deliver actionable competitive intelligence reports.
Find the Right Pack in Seconds
The Scientific Selector uses a guided, decision-tree approach to match your therapeutic area, development stage, and analytical need to the most relevant Evidence Packs -- no browsing required.
What is your therapeutic area?
What stage is your program?
What decision do you need to support?
Recommended: Oncology Trial Design Pack (ONC-001) -- 97% relevance
Evidence Integrity by Design
Every output produced by an Evidence Pack is built on three pillars: verifiable citations, calibrated confidence, and complete provenance.
Verifiable Citations
Every factual claim is linked to its source with DOI, PubMed ID, or database accession number. No unsourced assertions reach the final deliverable. Reviewers can trace any statement back to its origin in seconds.
Calibrated Confidence
Confidence scores are computed from source quality tiers, inter-source concordance, evidence recency, and sample size. Scores below the pack threshold trigger automatic uncertainty flagging and additional source retrieval.
Complete Provenance
The full evidence chain is preserved: which sources were queried, what was retrieved, how agents reasoned, and where each output element originated. This audit trail is exportable and meets GxP documentation expectations.
Validation Framework
Every Evidence Pack undergoes a multi-stage validation process before reaching Published status. Our framework is informed by ICH guidelines, FDA guidance on AI/ML in drug development, and established principles of systematic evidence review.
Source Qualification
Evidence sources are tiered by reliability: peer-reviewed publications, regulatory databases, and preprints each receive appropriate weight.
Cross-Validation
Key assertions are validated against multiple independent sources. Conflicting evidence is surfaced, not suppressed.
Expert Review
Subject-matter experts review pack outputs against known ground truth before publication. Edge cases and limitations are documented.
Continuous Monitoring
Published packs are re-validated when source data is updated. Version history and changelogs maintain full traceability.
Pack Lifecycle
Draft
Initial configuration of evidence sources, agent workflows, and output schemas.
Validated
Passed source qualification, cross-validation, and expert review gates.
Published
Approved for production use with documented confidence thresholds and limitations.
Monitored
Continuous re-validation against updated sources with automated drift detection.
Enterprise Ready
Built for regulated industries. BrewBio meets the security, compliance, and audit requirements expected by pharmaceutical and biotech organizations.
Data Security
- End-to-end encryption at rest and in transit
- Tenant-isolated data environments
- No training on customer data
- SOC 2 Type II aligned controls
Regulatory Compliance
- GxP-compatible audit trails
- 21 CFR Part 11 readiness
- GDPR and HIPAA safeguards
- Validated system documentation
Team & Access Control
- Role-based access with fine-grained permissions
- SSO / SAML integration
- Activity logging and session management
- Organizational hierarchy support
Audit & Traceability
- Immutable execution logs
- Version-controlled pack definitions
- Exportable provenance records
- Change control documentation
Usage Analytics
- Pack execution history and metrics
- Confidence score distributions
- Team utilization dashboards
- Export to BI platforms
Integration & API
- RESTful API for pack execution
- Webhook notifications
- Bulk execution support
- Custom output format templates