Fastrial AI+ is the AI operating layer embedded across Medigen Suite, built for compliance with ICH E6 R3 and 21 CFR Part 11. It connects clinical data, imaging, safety, documentation, and operational knowledge into governed AI workflows – built to help sponsors, CROs, and clinical teams run faster, smarter, and more compliant trials.
AI That Connects the Entire Clinical Trial Environment
Clinical development is under pressure from every direction — longer protocols, tighter budgets, rising regulatory scrutiny, and data volumes that outpace manual review capacity. The industry has responded with AI tools, but most remain disconnected: a model for recruitment here, an assistant for coding there.
Point solutions create point improvements. What moves trials forward is AI embedded across the entire operating environment — connected, governed, and working from the same clinical data.
What Fastrial AI+ Does
Fastrial AI+ is not a chatbot or a bolt-on module. It is the intelligence layer built into Medigen Suite — making every function context-aware. Clinical data, documents, protocols, SOPs, and imaging stop being static files. They become active, queryable knowledge assets that drive governed AI workflows across the full trial lifecycle.
| Domain | How AI Changes It |
| Study Setup & Protocol | AI-assisted authoring, feasibility analysis, and version control — fewer drafting cycles, less deviation risk. |
| Data Capture & Control | Embedded anomaly flagging and query management — better completeness at source. |
| Imaging | AI-powered review integrated within the trial environment — faster read cycles, in clinical context. |
| Safety Workflows | Governed AI for coding, signal support, and narrative generation — reduced burden, maintained oversight. |
| Monitoring & Risk | Risk-based signals and site performance indicators — targeted oversight, not calendar-driven monitoring. |
| Documentation & Compliance | AI-enabled drafting and review tools — regulatory productivity built into the workflow. |
| Training | Intelligent knowledge delivery that keeps teams current with protocol changes in real time. |
Governed AI Built for ICH E6 R3 Compliance
Deploying AI in a regulated clinical environment demands more than capability – it demands accountability. Every AI-influenced action must be traceable, every output auditable. Compliance with ICH E6 R3 (ICH GCP E6 (R3)) and 21 CFR Part 11 is non-negotiable.
Fastrial AI+ is designed around governed AI workflows, not unconstrained outputs. Human oversight is built into every workflow stage. Sponsors and CROs retain full control — AI accelerates; it does not replace accountability.
Built for Sponsors, CROs, and Clinical Operations Teams
Frequently Asked Questions
What is Fastrial AI+?
Fastrial AI+ is the AI operating layer embedded across Medigen Suite. It connects clinical data, imaging, safety, monitoring, documentation, and training into governed workflows for sponsors, CROs, and clinical teams.
Who is Fastrial AI+ designed for?
Sponsors, CROs, and clinical operations teams who need governed AI embedded directly in their eClinical environment — not bolted on as a separate tool.
How does Fastrial AI+ differ from standalone AI tools?
It operates as a unified layer across the full Medigen Suite platform — covering the entire trial lifecycle within a single governed environment, rather than addressing one function in isolation.
How does Fastrial AI+ support ICH E6 R3 compliance?
ICH E6 R3 raises expectations for data integrity, risk-based oversight, and accountability in computerized systems. Fastrial AI+ supports this with governed workflows, full traceability of every AI-influenced action, human oversight at each stage, and 21 CFR Part 11-compliant controls.
Is Fastrial AI+ built for regulatory compliance?
Yes. Governed workflows, full traceability, and human oversight are built in from the ground up — aligned with ICH GCP E6 (R3), and data integrity requirements.
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See how Fastrial AI+ and Medigen Suite can transform your clinical operations.
