FICS Product
Safety
Safety reporting that is integrated, not bolted on. Detect signals earlier with data that flows directly from your trial.
What It Is
FICS Safety provides integrated adverse event capture, signal detection, and safety reporting directly within the clinical trial workflow. Because safety data originates from the same unified data layer as EDC and CTMS, there are no delays from cross-system transfers or manual reconciliation — enabling earlier detection and faster reporting.
Who It's For
Safety scientists, pharmacovigilance teams, medical monitors, and regulatory affairs professionals who need timely, accurate safety data without the overhead of disconnected safety databases.
Why FICS
Why It's Better with FICS
Earlier safety signal detection — AE data flows in real-time from EDC, not via batch transfers
Unified with clinical data — no reconciliation between safety and efficacy datasets
Automated narrative generation and regulatory report drafting with AI assistance
Real-time dashboards for ongoing safety monitoring across sites and studies
Regulatory-grade audit trail from point of capture through submission
Integrated with CTMS for automatic safety milestone and task tracking
Ready for Clinical Development 2.0?
Partner with Pi Health and experience clinical trials reimagined: smarter, faster, and globally scalable.
Request a Demo