An Intelligent, Integrated Platform
Six purpose-built modules and four AI agents — designed to work together across BA/BE, Phase 1–3, and Real World Studies for CROs worldwide.
Agentic Orchestration
Specialized AI agents run autonomously in the background, handling the high-volume, error-prone tasks that slow down clinical teams.
Study Builder Agent
Protocol in → Study ready
Upload your protocol PDF or Word document and the Study Builder Agent reads it, extracts visit schedules, assessments, endpoints, and inclusion/exclusion criteria, and generates a complete CRF structure and study configuration — ready for your review. What used to take weeks of back-and-forth now takes hours.
Capabilities
- Protocol parsing and structured data extraction
- Automated CRF library matching and gap identification
- Visit schedule and window generation
- Edit check specification pre-population
- Study configuration diff and change tracking
Protocol → Annotated eCRF Agent
From blank CRF to CDISC-annotated in minutes
Takes your finalized CRF and protocol and generates a CDISC-annotated eCRF with SDTM domain, variable, and codelist annotations pre-populated. Dramatically reduces the time from database lock to SDTM dataset production.
Capabilities
- Automated SDTM domain and variable suggestion
- Codelist and controlled terminology mapping
- Supplemental qualifier identification
- Annotation PDF generation
- SDTM mapping specification draft output
Medical Coding Agent
Faster, consistent, auditable coding
Automatically codes adverse event terms to MedDRA and concomitant medications to WHO Drug dictionary using AI-assisted matching. Uncertain cases are flagged for human-in-the-loop review with suggested codes and rationale, ensuring speed without sacrificing accuracy.
Capabilities
- MedDRA LLT/PT/SOC coding with confidence scores
- WHO Drug ATC coding and dictionary matching
- Verbatim-to-coded term suggestion with audit trail
- Human review queue for low-confidence matches
- Coding report and reconciliation outputs
Discrepancy Management Agent
Every data issue found, queried, and tracked
Continuously monitors incoming EDC data for missing values, range violations, cross-form inconsistencies, and protocol deviations. Raises queries automatically with context-aware rationale, routes them to the correct role, and tracks resolution — reducing query cycle time significantly.
Capabilities
- Real-time data surveillance across all CRFs
- Context-aware query text generation
- Role-based query routing (site, CRA, medical monitor)
- Escalation rules and SLA tracking
- Discrepancy trend dashboards for risk-based monitoring
Platform Modules
Use all six modules as an integrated suite, or connect individual modules to your existing infrastructure.
Electronic Data Capture
Skaigen's EDC is the backbone of your clinical data operations. Purpose-built for BA/BE, Phase 1–3, and Real World Studies, it enables rapid study builds driven by your protocol, real-time validation, and clean data delivery.
Request DemoKey Features
- Drag-and-drop CRF builder with reusable libraries
- Real-time cross-form edit checks and derivations
- Multi-site data entry with role-based access control
- AI-powered Discrepancy Management Agent for automated query raising
- Full audit trail compliant with 21 CFR Part 11 and ICH E6
- Offline data entry with automatic sync
- Integration with Lab, CTMS, and submission modules
- One-click SDTM-ready data export
Electronic Patient Reported Outcomes
Capture subject-reported data directly from phones or tablets. Skaigen ePRO eliminates paper diaries, reduces transcription errors, and improves compliance with automated reminders and real-time visibility.
Request DemoKey Features
- iOS and Android native apps with offline support
- Configurable assessments, diaries, and questionnaires
- Automated push notifications and compliance tracking
- Multilingual support for global study deployment
- Real-time compliance dashboards for study teams
- eCOA (Electronic Clinical Outcome Assessments) ready
- Direct integration with EDC for seamless data flow
- Subject anonymisation and GDPR/HIPAA data privacy controls
Real-Time Monitoring System
Give your monitors and sponsors live visibility into study health. RTMS aggregates data from all modules and surfaces actionable insights — from enrolment lag to safety signals — without waiting for periodic reports.
Request DemoKey Features
- Configurable real-time dashboards by role (CRA, monitor, sponsor)
- Safety signal detection and automated alerts
- Enrolment velocity tracking vs. planned targets
- Protocol deviation tracking and trending
- Site performance scorecards across studies
- Risk-based monitoring (RBM) workflow support
- Email and SMS alert configurability
- Exportable reports for sponsor and regulatory review
Clinical Trial Management System
A fully standalone or tightly integrated CTMS covering the complete operational lifecycle of your studies — from site selection and regulatory document tracking to patient enrolment and investigator payments. Works across all study types and global geographies.
Request DemoKey Features
- Site feasibility, activation, and close-out workflow
- Regulatory document repository (eTMF-ready, ICH E6 R3)
- Subject enrolment, screening, and randomisation tracking
- Visit scheduling, completion, and deviation tracking
- Investigator and vendor contract management
- Budget tracking and milestone-based payment triggers
- IRB/IEC/REC submission and approval tracking
- CRA visit reports, action items, and CAPA management
Laboratory Information Management
Purpose-built for CRO laboratory operations. From sample receipt to result sign-off, Skaigen Lab Management ensures complete traceability, automated flagging, and seamless data transfer to EDC and biostatistics teams.
Request DemoKey Features
- Sample barcode tracking from collection to analysis
- PK (pharmacokinetic) sample scheduling and tracking
- Safety lab result entry with reference range auto-flagging
- Chain-of-custody documentation
- Instrument interface for major lab analysers
- Lab-to-EDC data transfer with validation
- SOP-based workflow management
- Full audit trail for GCP compliance
End-to-End Submission Pipeline
The full journey — from protocol-driven study build through SDTM and ADaM dataset generation to eCTD packaging — in a single connected, audited platform. Reduce cycle times and eliminate handoff errors across FDA, EMA, CDSCO, and PMDA submissions.
Request DemoKey Features
- AI Protocol → Annotated eCRF Agent for automated CRF mapping
- CDISC SDTM and ADaM dataset programming environment
- Pinnacle 21 validation integration
- TFL (Tables, Figures, and Listings) production
- eCTD publisher and submission package assembly
- FDA, EMA, CDSCO, PMDA submission support
- Define.xml and Reviewer's Guide generation
- Version-controlled document management
See the Full Platform in Action
Schedule a personalised demo and discover how Skaigen's agents and modules fit your study portfolio.
Request a Demo