Implement Exact-AI
Replace & Empower Legacy CROs with Exact-AI
The pharmaceutical industry has relied on expensive CRO services for decades, approaches that are slow, incomplete, and costly. ArcaScience's Exact-AI delivers what CROs couldn't in a fraction of a price & time, with AI regulators already trust.
Strategic Decisions made with true intelligence
By automating data aggregation, signal detection, and report generation, we eliminate data wrangling. The result: +5% drug approval, faster regulatory filings, stronger evidence packages, and better-informed go/no-go decisions.
How we ensure unbiased AI coverage
Trained by Clinicians
Bias in AI can compound existing healthcare disparities and distort benefit-risk evaluations. For 8 years, ArcaScience's 24 Ensemble-AI Model have been trained by clinicians, ensuring predictions reflect medical reality
Continuous Validation
Our models undergo continuous revalidation against diverse clinical populations & therapeutic areas. We synthesize global evidence to deliver impartial, context-aware insights qualified by FDA & EMA in 2025 & 2026.
Every insight is traceable to its source
No Black Box. Only Auditable Intelligence.
In pharmaceutical decision-making, "black box" AI is unacceptable. ArcaScience's platform ensures complete transparency: every benefit-risk signal, safety alert, or efficacy insight links directly to its originating data source, whether it is clinical trial records, peer-reviewed literature, or real-world evidence databases.
ArcaScience is about Exact-AI
Our AS Profiling Base 100b® maintains full citation metadata for over 100 billion data points, enabling regulatory reviewers and clinical teams to validate findings instantly, providing only auditable, source-backed intelligence.
Customized to specific pathologies
Every Therapeutic Area Has Unique Requirements
ArcaScience BRA Platform already proven approach fits within our clients' Business Units. Oncology demands nuanced tradeoffs between survival gains and toxicity. Rare diseases require extrapolation from limited populations. Dermatology prioritizes quality-of-life alongside efficacy.
Configure Endpoints, Comparators, and Weighting
ArcaScience Platform adapts to every therapeutic context. Users defines endpoint hierarchies, configure comparator strategies, and weight benefit-risk dimensions according to regulatory expectations and HTA frameworks specific to indications.
- Dermatology
- Immuno-Inflammation
- Oncology
- Rare Diseases
- Vaccines
- Cardiovascular
You have more questions ?
Our fastest implementations range from minutes for SaaS access to about one week for a Private Cloud setup. One product, one indication, public and/or internal data, plus one reviewer: output delivered within a week, with no automatic roll-over into a larger program.
EEA-based and self-hosted, with zero retention and no training on your data. The pilot uses public data only, so nothing of yours ever moves.
Publications aside, ask us for a Blind Approval. We give you access to the platform, or one of its outputs, and deliver a single, fully worked benefit-risk evaluation on your molecule and target, so you can measure us against your internal standards.
The ArcaScience BRA Platform was reviewed by the FDA in 2025 and qualified on both its technology and its outputs. Beyond that, we operationalize the frameworks regulators already use: the platform delivers decision support and submission-ready deliverables. You remain the MAH and the accountable party, while benefiting from the platform's credibility and efficiency.
Our business model is milestone-based: you either win, or you lose nothing. We even encourage clients to work the same problem in parallel if they wish: it makes benchmarking easy and demonstrates the ArcaScience Platform's value more clearly. You should own the capability; let us own the delivery.
Yes, ArcaScience Platform is easily integrated into internal pharma IT standards since 2023