ArcaScience
ArcaScience provides an AI-powered benefit-risk decision engine for pharmaceutical companies, using 24 clinician-trained AI models and a 100B+ data point proprietary database to support regulatory submissions, early-phase decisions, and post-approval surveillance across the drug lifecycle.
- Company typePrivate
- Founded2018
- HeadquartersParis, France
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What ArcaScience does
ArcaScience is a B2B SaaS company that applies AI to drug benefit-risk assessment for pharmaceutical and biotech companies across the full drug lifecycle—from preclinical framing through regulatory submission and post-approval surveillance. Founded in 2018 in Paris by pharmacoepidemiology experts including CEO Romain Clement, the company targets the fragmented manual workflows that currently make benefit-risk evaluations take 12-18 months and contribute to high drug development failure rates (9 of 10 drugs fail, at an average cost of $2.3B per approval). The company reports a customer base of 20+ pharmaceutical leaders including Sanofi and AstraZeneca, with 50+ regulatory submissions supported across 12 therapeutic areas.
The company's core technology pairs a proprietary 100+ billion data point database (AS Profiling Base 100b®) covering scientific literature, real-world evidence, and regulatory submissions, with 24 ensemble AI models trained by clinicians using a 6-step BRAT methodology validated against FDA recommendations. The platform is delivered as five integrated modules: predictive benefit-risk assessment for early-phase decisions, AI-assisted regulatory submission support (generating PSUR, RMP, and CTD 2.5 B-R documents), continuous evidence monitoring for post-approval safety surveillance, clinical landscape analysis for protocol design, and disease/therapeutic landscape analysis for portfolio go/no-go decisions. The platform is compliant with FDA 21 CFR Part 11, GDPR, and ISO 27001, and achieved formal FDA and EMA AI model qualification in 2025-2026. The Exact-AI approach provides full source traceability with a stated 0% hallucination rate.
ArcaScience monetizes through enterprise SaaS subscriptions sold via direct field sales to top 10 pharmaceutical and biotech clients, reporting 100% win rates against traditional consulting firms and outcomes of 60-80% reductions in evaluation time and cost. The Scientific Committee holds approximately 25% equity, aligning scientific governance with shareholder interests. In September 2025, the company closed a $7M seed round led by The Moon Venture to fund US and UK market expansion, launch a patient-facing solution, recruit a Chief Medical Officer, and deepen focus on pediatric brain cancer and dermatological diseases. Operations are based in Paris and Sunnyvale, California, with a 60+ person team across 15+ nationalities.
ArcaScience firmographics
Firmographics- Name
- ArcaScience
- Legal name
- ArcaScience SAS
- Website
- https://arcascience.ai
- Company type
- Private
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- ArcaScience provides an AI-powered benefit-risk decision engine for pharmaceutical companies, using 24 clinician-trained AI models and a 100B+ data point proprietary database to support regulatory submissions, early-phase decisions, and post-approval surveillance across the drug lifecycle.
- Ownership category
- akta.pro rank
ArcaScience industry classification
Industry- Product category
- Pharmaceutical Benefit-Risk Assessment Software
- akta.pro primary industry
- AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO)
- akta.pro secondary industries
- Audit, Explainability & Accountability Tooling (traceability, reporting) (HDAAAKAL), Model Governance, Risk & Compliance (GRC) Platforms (HDAAAKAA)
Keywords
Where ArcaScience is headquartered
LocationHeadquarters
- HQ city
- Paris
- HQ country
- France
- HQ region
- Europe
Offices3 records
Markets served
ArcaScience business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- SaaS Platform Subscription: ArcaScience operates as a B2B SaaS platform providing AI-powered benefit-risk assessment tools to pharmaceutical companies on a subscription basis, with enterprise contracts for regulatory submission support
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
ArcaScience product offering
Product offeringCore offering
ArcaScience provides an AI-powered benefit-risk decision engine for pharmaceutical companies that supports the full drug lifecycle from preclinical framing through post-approval surveillance. The platform leverages 24 ensemble AI models and a proprietary database of 100+ billion data points to deliver regulatory-grade benefit-risk assessments, predictive safety analysis, and submission-ready documentation for FDA, EMA, and PMDA-aligned submissions.
Product overview
ArcaScience offers a unified AI-powered benefit-risk assessment platform consisting of the core ArcaScience Platform powered by the AS Profiling Base 100b® database. The platform provides five integrated modules: Predictive Benefit-Risk Assessment for early-phase decision-making, AI-Assisted Benefit-Risk Assessment for regulatory submissions, Continuous Evidence Monitoring for post-approval surveillance, Clinical Landscape Analysis for protocol design, and Disease & Therapeutic Landscape Analysis for strategic go/no-go decisions. The platform is complemented by ArcaScience's Exact-AI approach, which combines 24 ensemble AI models with human expertise to deliver transparent, auditable intelligence across the entire drug lifecycle from preclinical development through post-market surveillance.
Differentiator
Problem solved
Functional benefit
Products and services
- ArcaScience Platform End-to-end AI-powered benefit-risk decision engine for pharmaceutical companies, supporting the full drug lifecycle from preclinical framing to post-approval surveillance. Trusted by 20+ pharmaceutical leaders across 7 years of successful regulatory submissions.
- AS Profiling Base 100b® Proprietary database containing 100+ billion pharmaceutical data points layering 100% of publicly available scientific literature, real-world evidence, and regulatory submissions. Powers the benefit-risk analysis engine with comprehensive evidence synthesis across 12,000+ evidence sources and 3,000+ articles.
- Predictive Benefit-Risk Assessment Early-phase decision-making module enabling R&D teams to evaluate molecules and make faster, better-informed development decisions. Delivers comprehensive BRA in 3-4 weeks by analyzing 11,700 evidence sources across clinical trials, publications, and regulatory data.
- AI-Assisted Benefit-Risk Assessment for Regulatory Submission Regulatory submission module completing end-to-end BRA in under one month with systematic evidence identification, extraction, and synthesis. Generates submission-ready documents including PSUR, RMP, and CTD 2.5 B-R sections with full audit trail.
- Continuous Evidence Monitoring for Benefit-Risk Surveillance Post-approval surveillance module providing automated continuous screening of PubMed, MEDLINE, and ClinicalTrials.gov. Enables early detection of emerging safety signals, efficacy shifts, and population-specific benefit-risk changes with full audit trail.
- Clinical Landscape Analysis for Protocol Design & Regulatory Strategy Protocol design module delivering comprehensive clinical landscape and endpoint analysis across 5 target conditions in under one month. Covers clinical studies, meta-analyses, and systematic reviews with AI-powered extraction and normalization of endpoint strategies.
- Disease & Therapeutic Landscape Analysis Disease exploration module providing Investment Committee-grade disease intelligence delivered in under three weeks. Assesses 12,000+ evidence sources, extracts 3,000+ articles across peer-reviewed publications, registries, meta-analyses, and observational studies.
Quantifiable outcome
- 60% reduction in evaluation time
- +6 more outcomes
Companies that use ArcaScience
Customer profileNamed customers6 records
Segments2 records
Ideal customer profiles3 records
ArcaScience technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
AI capability7 records
Feature5 records
ArcaScience partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Research Institutions & Regulatory BodiesminorCollaborative partnerships with leading research institutions, regulatory bodies, and pharmaceutical innovators to continuously refine the platform with real-world feedback.
Scale indicators7 records
Recent moves8 records
Expansion highlights6 records
ArcaScience competitors and assessment
Company assessmentDirect peers
- ConcertAI: AI and real-world evidence platform for oncology and clinical research, serving top pharma companies. Comparable in pharma AI, RWE synthesis, and enterprise go-to-market motion.
- Owkin: France-based AI-for-pharma company that builds AI models on multimodal patient data to accelerate drug discovery and development. Closely comparable to ArcaScience in origin, technology stack, and pharma customer base.
- Saama Technologies: AI-driven clinical analytics platform serving pharma and life sciences with data management, clinical trial analytics, and evidence synthesis. Highly comparable to ArcaScience's clinical landscape and regulatory submission use cases.
- Aetion: Real-world evidence analytics platform used by regulators, payers, and pharma for evidence-based decisions. Comparable in regulatory-grade evidence synthesis and pharma customer base.
Broad incumbents
- Veeva Systems: Dominant cloud software provider for life sciences, including clinical, regulatory, and safety applications. Overlaps with ArcaScience in regulatory submission tooling but serves a much broader pharma workflow footprint.
- IQVIA: Largest global CRO with proprietary RWE, technology platforms, and deep top-10 pharma relationships. Could build or acquire AI benefit-risk capability and represents the most significant scale threat to ArcaScience.
- Medidata Solutions (Dassault Systèmes): Leading clinical trial technology platform owned by Dassault Systèmes, with EDC, RWE, and AI-augmented trial analytics. Comparable in pharma data infrastructure and clinical development workflow.
Emerging players
- Tempus Labs: AI-driven precision medicine company with massive multi-modal data library across oncology and other diseases. Comparable in data scale, AI/ML platform approach, and pharma/biotech customers.
- Insilico Medicine: AI-driven drug discovery and clinical development company, with overlap to ArcaScience in clinical evidence analysis and pharma AI tooling, though more focused on target discovery.
- Unlearn.AI: AI platform for clinical trial design and synthetic control arms in pharma research. Comparable in applying AI to compress and de-risk pharma development workflows.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
ArcaScience social profiles
Digital presenceArcaScience compliance and trust
Trust signalCompliance3 records
ArcaScience financial estimates
Financial estimateRevenue estimate
Valuation estimate
ArcaScience leadership team
Management profileNumber of profiles
Profiles8 records
ArcaScience funding detail
Funding detailFunding overview
Funding rounds2 records
Investors6 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ArcaScience M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ArcaScience
What does ArcaScience do?
ArcaScience provides an AI-powered benefit-risk decision engine for pharmaceutical companies that supports the full drug lifecycle from preclinical framing through post-approval surveillance. The platform leverages 24 ensemble AI models and a proprietary database of 100+ billion data points to deliver regulatory-grade benefit-risk assessments, predictive safety analysis, and submission-ready documentation for FDA, EMA, and PMDA-aligned submissions.
Is ArcaScience a public or private company?
ArcaScience is a private company. It is classified as venture growth investor backed and is currently operating.
When was ArcaScience founded?
ArcaScience was founded in 2018. It employs 1 to 10 people.
Where is ArcaScience based?
ArcaScience is headquartered in Paris, France, in the Europe region.
How does ArcaScience make money?
One revenue line is on record: saaS Platform Subscription.
Who are ArcaScience's main competitors?
Direct peers on record are ConcertAI, Owkin, Saama Technologies and Aetion. Broad incumbents are Veeva Systems, IQVIA and Medidata Solutions (Dassault Systèmes). Emerging players are Tempus Labs, Insilico Medicine and Unlearn.AI.
Does ArcaScience have an API?
No public API is recorded for ArcaScience.
What industry is ArcaScience in?
ArcaScience's product category is Pharmaceutical Benefit-Risk Assessment Software. Its primary akta.pro industry code is HLAGAJAO, AI/ML Platforms for Drug Discovery & Experiment Optimization, with a secondary code of HDAAAKAL, Audit, Explainability & Accountability Tooling (traceability, reporting).