Explore by Lifecycle Phase
Phase-Specific Benefit-Risk Solutions
Each phase of drug development demands different data sources, analytical models, and regulatory outputs. ArcaScience configures its platform for the specific BRA challenges at every stage.
Phase 1 of 6
Preclinical & Phase I
Early safety profiling from non-clinical data. Identify dose-limiting toxicities, establish initial safety margins, and build the preclinical benefit-risk framework before first-in-human studies.
Phase 2 of 6
Phase II
Dose-response optimization and early efficacy-safety tradeoffs. Quantify emerging safety signals against preliminary efficacy endpoints to guide Phase III design.
Phase 3 of 6
Phase III
Comprehensive pivotal trial analysis. Aggregate safety data across multi-thousand patient trials, detect rare AEs, and build the integrated benefit-risk profile for regulatory submission.
Phase 4 of 6
Regulatory Submission
Submission-ready BRA documentation. Generate PSUR/PBRER, RMP, CTD Module 2.5, and HEOR reports directly from the analytical pipeline for FDA, EMA, and PMDA filings.
Phase 5 of 6
Post-Marketing Surveillance
Continuous real-world safety monitoring. Detect emerging signals from FAERS, EudraVigilance, and spontaneous reports with AI-powered disproportionality analysis and trend forecasting.
Phase 6 of 6
Market Access & HTA
Health technology assessment and value-based BRA. Generate comparative effectiveness evidence, NNT/NNH analysis, and payer-ready benefit-risk communication for reimbursement decisions.
Platform Capabilities
How ArcaScience Adapts Across Phases
Our three integrated modules evolve with your program, shifting data sources, analytical models, and output formats as your drug moves through development.
Phase-Adaptive Data Sources
Data sources shift from preclinical databases and toxicology repositories in early phases, to clinical trial registries and safety databases in pivotal trials, to FAERS, EudraVigilance, and real-world evidence in post-marketing. Each phase ingests the data most relevant to its BRA requirements.
Explore Data Engine →Phase-Specific AI Models
Models evolve from dose-toxicity relationship modeling in Phase I, to dose-response optimization in Phase II, to multi-endpoint meta-analysis and rare event detection in Phase III, to real-world signal detection and disproportionality analysis in post-marketing.
Explore AI Models →Phase-Matched Reports
Output types change from IND safety summaries and investigator brochures in early development, to integrated safety summaries and CTD Module 2.5 at submission, to PSUR/PBRER and RMP for marketed products, to HEOR value dossiers and HTA submissions for market access.
Explore Outputs →