21 CFR Part 11 and HIPAA Compliant eClinical Suite

Regulatory Compliance

TrialStat's entire Unified eClinical Suite is developed and deployed with an Agile Methodology and specifically engineered to comply with FDA 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures. TrialStat maintains a Master Validation Plan and Change Control procedures to control and document the design, development, testing and release of our eClinical products.

Checklist is written by businessman on computer screen.

21 CFR Part 11 Compliant

HIPPA Compliant

GDPR Compliant

Privacy Shield

Electronic Signatures

Comprehensive Audit Trails

SAS 70 Type II

CAPA Program

Quality Management System

TrialStat's Quality Management System ensures we remain in compliance with all regulatory requirements and industry guidance.

We have successfully completed hundreds of client and project audits and we look forward to working with you on your clinical program.


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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.