How Pharmaceutical Companies Use ArcaScience to Make Benefit-Risk Decisions

Specific programs. Measurable outcomes. Across 12 therapeutic areas.

50+

Submissions Accepted

20+

Clients

12

Therapeutic Areas

100%

Acceptance Rate

Oncology Post-Marketing

AstraZeneca — Oncology BRA Acceleration

68% reduction in BRA cycle time and 3x more signals detected across checkpoint inhibitor portfolio using AI-powered analysis.

68% faster BRA

Rare Disease Submission

Sanofi — Rare Disease BRA Transformation

52% faster regulatory submissions and 85% accuracy improvement in signal detection for rare disease portfolio.

52% faster submissions

Immunology Post-Marketing

Roche — Real-World Evidence Integration

75% reduction in data preparation time with unified safety view across 12 data sources and real-time signal monitoring.

12 sources unified

Cross-TA Post-Marketing

Novartis — Portfolio PSUR Automation

60% reduction in PSUR preparation time across 300+ products with zero regulatory deadline misses and $12M annual savings.

$12M saved annually

Multiple TAs CRO Partner

ICON — Scaling PV with AI

45% operational efficiency gain and 90% reduction in QC findings across 200+ sponsor compounds.

200+ compounds

Neurology Academic

Paris Brain Institute — COVID-19 Literature Analysis

Rapid evidence synthesis of neurological adverse events from 12,000+ COVID-19 publications in 3 weeks.

Rapid synthesis

Oncology BRA Case Study

Download the full oncology benefit-risk analysis case study detailing how ArcaScience delivered a comprehensive BRA in 5 weeks with 60% time reduction and 100B+ data points analyzed.

Download Case Study

Discuss a Similar Challenge

Talk to a scientist about how ArcaScience can accelerate your benefit-risk analysis process. Tailored to your therapeutic area, development phase, and regulatory authority.

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