The Intelligent Platform for Modern Clinical Trials
Skaigen orchestrates AI agents across every phase of your study — from protocol ingestion and study setup to data capture, medical coding, discrepancy management, and regulatory submission. Built for BA/BE, Phase 1–3, and Real World Studies worldwide.
AI Agents Working For Your Study Team
Specialized agents run autonomously in the background — handling the repetitive, error-prone work so your team can focus on what matters.
Study Builder Agent
Reads the protocol and automatically generates CRF structures, visit schedules, edit checks, and study configuration — cutting setup time from weeks to hours.
Protocol → Annotated eCRF Agent
Parses protocol documents and produces CDISC-annotated electronic CRFs with domain and variable mapping pre-populated, ready for review.
Medical Coding Agent
Automatically codes adverse events to MedDRA and concomitant medications to WHO Drug dictionary, with human-in-the-loop review for edge cases.
Discrepancy Management Agent
Continuously monitors incoming data, raises queries with context-aware rationale, routes to the right role, and tracks resolution — autonomously.
One Platform, Complete Coverage
Six purpose-built modules that work seamlessly together — or independently alongside your existing tools.
Electronic Data Capture
Capture, validate, and manage clinical trial data with a purpose-built EDC designed for BA/BE, Phase 1–3, and Real World Studies.
Electronic Patient Reported Outcomes
Mobile-first tools for subjects to report outcomes directly, reducing transcription errors and improving data quality across all study types.
Real-Time Monitoring System
Live dashboards and alerts that give sponsors and monitors complete visibility into study progress, protocol deviations, and safety signals.
Clinical Trial Management System
Standalone or integrated CTMS for end-to-end trial operations — site activation, enrolment tracking, milestone management, and TMF.
Laboratory Information Management
Integrated lab workflows covering sample tracking, PK analysis, safety labs, and automated flagging of out-of-range values.
End-to-End Submission Pipeline
From protocol study build through SDTM/ADaM programming to eCTD package generation — one connected, audited workflow.
Expert Clinical Data Services
Beyond software, our experienced team provides end-to-end clinical data services — from data management and SDTM/ADaM programming to full regulatory submission packages for FDA, EMA, CDSCO, and global agencies.
- Clinical Data Management
- Data Programming (SAS / Python)
- SDTM Mapping & Validation
- ADaM Datasets & TFLs
- Regulatory Submission Packages
From First Patient to Final Submission
One team, one platform, one workflow.
Why Skaigen?
A new generation of clinical research technology — intelligent, integrated, and built for how modern CROs operate.
AI-Agentic Orchestration
Multiple specialized AI agents handle study setup, coding, monitoring, and discrepancy management — so your team focuses on science, not admin.
Rapid Study Setup
Protocol-driven automation configures studies in hours. Pre-built templates for BA/BE, Phase 1–3, and Real World Studies eliminate repetitive setup work.
Global Regulatory Coverage
21 CFR Part 11, GDPR, HIPAA, ICH E6 GCP, CDISC, and agency-specific submission standards built in — not added as an afterthought.
CRO-Centric by Design
Built by people who have run CRO operations. Multi-sponsor, multi-study architecture designed for how CROs actually work.
Built to the Highest Standards
Skaigen is designed for regulated environments. Our certifications and compliance frameworks give sponsors and CROs confidence from day one.
Ready to modernize your clinical operations?
Join CROs worldwide that are running faster, cleaner studies with Skaigen's agentic platform.