Manage Your AEs, SAEs & Regulatory Reporting

Manage All Safety Events Within EDC

TrialStat allows you to design Adverse Event and Serious Adverse Event forms directly within EDC. These forms are common, meaning they are available across visit time points preventing the need for duplicate entries. SAEs are naturally an extension of the associated AE form eliminating the need for reconciliation.

Track all of your safety events directly within EDC, complete your narratives, and generate your regulatory forms including MedWatch and others without having to use a 3rd party system, or integrate directly into your existing Safety Management System through our comprehensive API.

Doctor Holding Patient's Hands

Adverse Events

Serious Adverse Events

Generate Regulatory Forms Such As MedWatch

Integrated with 3rd Party Safety Systems

Integrated with 3rd Party CTMS Systems

Form Persists Across Visits

AEs and SAEs Integrated In a Single, Responsive Form

Capture Full Narratives

Integrated Notifications

Save time and resources by utilizing our integrated safety tracking and reporting tools.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?

A Unified eClinical Suite Delivering Real-Time Data

eConsent Module

Randomization Module

ePro (Patient Reported Outcomes) Module

Medical Coding Module

IWRS & Inventory Management

Vendor Neutral Imaging Archive (VNA)

Browser Based & Mobile Responsive

CTMS by SimpleTrials

Comprehensive Edit Checks

Dynamic Skip Logic

AE / SAE tracking

Fully Customizable eCRFs

Fully Customizable Data Review Status Work Flows

DICOM Image Viewer(s)

2-4 Week Build Time

Configurable Study Workflow

Real-Time Data Visualization

Make Critical Decisions Sooner

Flexible Data Capture

Bar Code Integration

Real-Time Monitoring, Reporting & Validation

Integrated Real-Time Reporting

Multi-Lingual Support

Replicate Entire Studies

40+ Standard Reports

Configurable Reports & Dashboards

Data Drill-Downs

See TrialStat In Action

Request Your Personalized Demo. Our Clinical Team will organize a tailored demonstration of TrialStat based on your specific study requirements. You'll see first hand how TrialStats unified features, blazing speed, configurable features and comprehensive functionality will help you run more efficient and cost effective studies.