A Fully Integrated eClinical Platform Designed For CROs

Streamline and simplify your clinical data management with a flexible suite of tools.

Compared to other EDC solutions on the market from MediData, DataTrack, Omnicomm and others, TrialStat is the most all-encompassing suite of study management tools that can be seamlessly connected to external data sources such as EMR, wearables, and other clinical and non-clinical data and information sources.

Business team in the office

Premium Modules and Capabilities

Randomization / IWRS

TrialStat EDC provides integrated IWRS functionality, allowing for any degree of randomization complexity.

Using TrialStat IWRS will enable sites to trigger randomization codes directly without leaving TrialStat EDC, and without the need or added cost of another software system.

Our user-friendly system implements the most current technologies and tools to ensure that your team can successfully randomize patients into your trial without complications or delays.

Click the diagram below to explore all of the features of the TrialStat eClinical Suite.

Medical Coding
Vendor Neutral Imaging Archive
Clinical Data Warehouse
Machine Learning & AI
3rd Party Systems Integration
Study Design and Validated Development

Fully Integrated With EDC

Any Degree of Randomization

Multiple Levels of Stratification

Randomize into Different Cohorts

Tie Into Inventory Management

Randomization Notifications

Simple randomization, Block randomization and Permuted block randomization

Randomization and Patient Enrolment Status Tracking

21 CFR Part 11 Compliant

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?

2-4 Week Build Time

CDASH Compliant CRF Library

Randomization / IWRS

Image Storage / Vendor Neutral Archive


ePRO / Patient Reported Outcomes

Medical Coding


AE / SAE Tracking + Regulatory Forms

HTML 5 Compliant DICOM Viewer - CE Class IIa certified

Patient Report Outcomes (ePRO)

Dynamic Skip Logic and Comprehensive Edit Checks

Configurable Study Workflow

Multi-Lingual Support

Real World Data & Evidence

Bespoke Machine Learning Programs

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, HIPAA, GDPR and FISMA. TrialStat maintains a Master Validation Plan and Change Control procedures.

GDPR and HIPAA Compliant

21 CFR Part 11

Good Documentation Practices

Privacy Shield

Electronic Signatures

Change Control Procedures

Full Audit Trail

SAS 70 Type II

CAPA Program

SOX Compliant Solutions

FISMA Compliance Solutions

Quality Management System

A Unified eClinical Suite Delivering Real-Time Data

Fully Unified eClinical Suite


ePro (Patient Reported Outcomes)

CDASH Compliant CRF Library

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

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.