Our Founding Story
Founded by Pharmacoepidemiology Experts
ArcaScience was founded by pharmacoepidemiology experts who recognized that benefit-risk assessment — the central question in drug development — was being conducted with inadequate tools.
Manual literature review, fragmented CRO engagements, and qualitative narratives were insufficient for the rigor and speed required by modern pharmaceutical development. Benefit-risk decisions affecting millions of patients deserved better analytical infrastructure.
We set out to build what didn't exist: a unified analytical platform that could ingest heterogeneous data, apply validated benefit-risk frameworks, and generate regulatory-grade outputs — with full transparency, reproducibility, and auditability.
Today, ArcaScience's platform has supported over 50 regulatory submissions, analyzed 100+ billion data points, and serves pharmaceutical companies at every stage of the drug lifecycle.
Romain Clement, Co-Founder & CEO
Mission & Vision
Our Commitment to Pharmaceutical Innovation
Mission
Improve the quality, consistency, and timeliness of benefit-risk analysis in pharmaceutical development.
We believe that benefit-risk assessment should not be a bottleneck in drug development. By integrating data intelligence, decision intelligence, and automated outputs into one validated platform, we enable pharmaceutical companies to conduct comprehensive benefit-risk analyses in weeks instead of months — with full regulatory traceability and reproducibility.
Vision
A world where no regulatory decision is made without comprehensive, AI-powered benefit-risk analysis.
The future of pharmaceutical development is data-driven, transparent, and patient-centered. We envision a regulatory ecosystem where every submission — from Phase I to post-marketing surveillance — is supported by structured, quantitative benefit-risk evidence. ArcaScience is building the infrastructure to make that vision a reality.
Company Timeline
Key Milestones Since 2018
2018
Founded in Paris
ArcaScience founded in Paris by pharmacoepidemiology experts with a mission to transform benefit-risk assessment through AI-driven analysis. Initial platform development begins with focus on data ingestion and MedDRA coding automation.
2019
First Pharma Client (Sanofi)
Sanofi becomes ArcaScience's first pharmaceutical client, deploying the platform for post-marketing signal detection and PSUR generation. Platform processes first 10 billion data points from FAERS and EudraVigilance.
2020
COVID-19 Rapid Deployment with Paris Brain Institute
ArcaScience platform deployed for rapid benefit-risk assessment of COVID-19 therapeutics in collaboration with Paris Brain Institute. Continuous signal monitoring configured for real-time safety surveillance during emergency use programs.
2021
Series A Funding — AS Profiling Base Reaches 100B Data Points
Raised Series A funding from The Moon Venture, Pleiade Venture, Plug&Play, and Bpifrance ($7M+). Investment enables expansion of AS Profiling Base to 100+ billion data points and development of Decision Intelligence module with BRAT framework and MCDA implementation.
2023
50+ Regulatory Submissions — 24 AI Models
ArcaScience platform reaches milestone of supporting 50+ regulatory submissions across FDA, EMA, and PMDA. 24 proprietary AI models now operational for signal detection, causal inference, and comparative effectiveness. 100% acceptance rate for submissions using platform-generated PSUR/PBRER and CTD Module 2.5 documents.
2024
US Expansion — Sunnyvale Office
Opened Sunnyvale office to serve US pharmaceutical clients and strengthen relationships with FDA. US operations team established for business development, client support, and regulatory affairs.
2025
Paris Brain Institute Research Collaboration for CNS Safety
Announced research collaboration with Paris Brain Institute (ICM) to advance AI methods for neurological drug safety assessment. Joint research program focused on developing novel signal detection algorithms for CNS therapeutics.
Team by the Numbers
A Multidisciplinary Team of Scientists, Engineers, and Operators
Team members globally
Scientists
Engineers
Operations
Offices: Paris & Sunnyvale
Nationalities represented
Global Presence
Two Offices. One Shared Mission.
Paris Headquarters
Our Paris office houses R&D, scientific operations, and platform engineering. Located in the heart of the city's biotech district, the Paris team drives core product development, maintains the AS Profiling Base, and collaborates with European pharmaceutical clients and research institutions.
Functions
R&D, Data Science, Platform Engineering, Regulatory Science
Location: 8 rue Jean-Antoine de Baif, 75013 Paris, France
Established: 2018
Sunnyvale Office
Our Sunnyvale office supports US operations, business development, and client success. Strategically located in the Bay Area, the Sunnyvale team serves North American pharmaceutical clients, manages FDA relationships, and coordinates deployments for US-based development programs.
Functions
US Operations, Business Development, Client Success, Regulatory Affairs
Location: 440 N Wolfe Rd, Sunnyvale, CA 94085, USA
Established: 2024
Investors
Backed by Leading Healthtech Investors
Raised $7M+ to accelerate platform development and global expansion.
