The Benefit-Risk Evaluation Challenge
Every molecule has a benefit-risk setting where it wins.
Today, teams can afford to test one at a time.
You File One Configuration of Millions
Indication, population, dose, endpoint, comparator, weighting: six axes, millions of possible settings, one committee pick made on three slides. Score the full space under FDA BRF, BRAT and CIOMS XII, then file the one that survives every framing.
Your Benefit-Risk Case Expired at Signature
4,000 new papers a day, a competitor readout, a label change: assessments frozen in documents age between board meetings. On ArcaScience, benefit-risk turns dynamic. Your assessment recomputes the day evidence lands, and the version regulators question is the version you hold.
Your Comparator Read Everything. Did You?
Miss one trial and reviewers find it first. ArcaScience scores your molecule against the world's most comprehensive benefit-risk evidence base: 100% of prequalified public sources & private sources, RWE and regulatory documents, every citation server-validated.
One Platform. Complete Visibility.
Six stages. From clinical framing to automated outputs
100B+ data points | In-house private AI models | Trusted by top 10 pharma companies
Clinical Framing
Protocol parameters setting (drug, dosage, comparator), establishing clinical design and decision criteria ensuring alignment across clinical, regulatory, and market access teams.
Every outcome assessed
ArcaScience runs the comparative assessment for each selected outcome, benefits and risks, drug and comparator, side by side. AI-generated analysis with evidence scoring. No manual data extraction, no spreadsheet.
Your judgment, built into the model
Remove irrelevant outcomes, reorder benefits and risks, and adjust weightings to reflect your submission strategy. The Value Tree updates in real time.
Your assessment, ready to defend
No more assembling results from scattered sources. ArcaScience structures your benefit–risk outputs in a single, interpretable view, ready to present to regulators, HTA bodies, or internal stakeholders.
"For the first time in our history, we successfully achieved a benefit-risk drill-down prediction based on 9x more insights, anticipating thromboembolic risks"
Global R&D Team
Philippe Peyre, Secretary General, Vice President, Sanofi.
Built by scientists.
Trusted by pharmaceutical leaders.
Founded in 2018 by pharmaceutical and medical experts, ArcaScience bridges cutting edge AI with regulatory science. Our platform supports benefit risk decisions across the entire drug lifecycle, from clinical development through post marketing surveillance.
Our Partners
Trusted by leading pharmaceutical companies, research institutions, and regulatory bodies worldwide.
50+ regulatory submissions supported |
12 therapeutic areas
Accelerate Decisions Across the Drug Lifecycle
From early-stage portfolio prioritization to post-marketing safety monitoring, ArcaScience adapts to your specific phase and therapeutic area. Explore how teams like yours leverage our platform at every critical milestone.
The Science Behind the Platform
ArcaScience was built to solve a $13 billion market problem: the lack of comprehensive, real-time benefit-risk intelligence. Our mission is to revolutionize drug evaluation and become the world leader in benefit-risk assessment: replacing legacy service models with transparent, AI-powered decision intelligence.
100B+ Data Points
The world's most comprehensive benefit-risk database (AS Profiling Base 100b®), layering 100% of publicly available scientific literature, RWE, and regulatory submissions.
Peer-Reviewed Methodologies
Published research validating our AI ensemble models for phenotyping, safety signal detection, and comparative effectiveness analysis.
Collaborative Partnerships
Working alongside leading research institutions, regulatory bodies, and pharmaceutical innovators to continuously refine our platform with real-world feedback.
Compliance by design
Pharmaceutical data demands the highest standards. ArcaScience is architected from the ground up to meet global regulatory requirements, ensuring your benefit-risk analyses are audit-ready and legally defensible.
Ready to Transform Your Benefit-Risk Evaluations?
Join 20+ pharmaceutical leaders who've cut evaluation time by 60% to 80% and costs by 70%. See how ArcaScience delivers the strongest clinical cases, through benefit-risk intelligence: from clinical framing to automated submissions.