About Skaigen
We exist because CROs worldwide deserve a clinical research platform built for the intelligence era — not legacy software from the 1990s with a fresh coat of paint.
Orchestrating AI to accelerate safe, high-quality clinical research
Skaigen was founded to bring agentic AI to clinical research operations. We believe the future of clinical trials isn't just digital — it's intelligent. Specialized AI agents handling study setup, data management, coding, and monitoring while human experts focus on scientific decisions.
Our platform serves CROs running BA/BE studies through Phase 1, 2, and 3 trials and Real World Studies — across every major regulatory jurisdiction.
The operating system for the world's clinical research organizations
We are building toward a future where every CRO — regardless of size or geography — can run studies that are faster to set up, cleaner to submit, and safer for patients. Starting with the studies CROs know best: BA/BE. Expanding to Phase 1–3 and Real World Evidence globally.
Clinical Research Deserves Better Technology
CROs have long relied on expensive, monolithic platforms built before smartphones existed — or on disconnected spreadsheets and paper processes that introduce data quality risks. Neither option is acceptable for an industry entrusted with patient safety and regulatory-grade data.
Meanwhile, AI is transforming every other knowledge-intensive industry. Skaigen applies the same agentic AI principles to clinical research: specialized agents that read protocols, build studies, code adverse events, and manage discrepancies — autonomously, with full audit trails.
This isn't automation bolted onto legacy software. It's a platform architected from the ground up for AI-orchestrated clinical operations — compliant with the regulations that matter and designed for global deployment.
Certifications & Standards
Skaigen is built for regulated environments. Current certifications and upcoming accreditations are listed below.
Our Values
Patient-Centric
Every feature traces back to improving data quality and, ultimately, patient safety in clinical trials.
Global Reach
We design for CROs operating across regulatory environments — FDA, EMA, CDSCO, PMDA, and beyond.
Compliance by Default
21 CFR Part 11, ICH E6 GCP, GDPR, HIPAA, and CDISC standards are baked in — not bolted on.
Continuous Innovation
We ship fast and listen to our customers. Agentic AI capabilities are at the core of our product roadmap.
The People Behind Skaigen
Founding Team
Combined decades of experience in clinical data management, regulatory submissions, and enterprise software — dedicated to transforming how CROs run studies.
Clinical Advisors
Senior biostatisticians, regulatory affairs specialists, and clinical research professionals guiding platform strategy across global markets.
Engineering Team
Full-stack engineers and AI researchers with deep domain expertise, building software that clinical professionals actually want to use.
Want to Learn More?
Get in touch to see how Skaigen can transform your clinical research operations.
Contact Us