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.

eConsent
ePRO
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

Comarketing and Joint Business Development Activities

As an eClinical Solutions provider, TrialStat operates withing a broad ecosystem of supporting technologies (CTMS, ETMF, Devices, Safety Systems, other EDC vendors, etc) as well as service providers (CROs, Data Management companies, Regulatory Consultants, Stats, Clinical Consultants, manufacturers, depots, etc.).

As such, we work closely with all of our partners on marketing joint business development activities. As a TrialStat partner you would benefit by participating in joint webinars, industry tradeshows, road shows, and collaborating on projects as well as receiving referrals.

To learn more, please contact us today using the contact form in top right corner, or sending an email to [email protected]

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?

eConsent Module

ePro (Patient Reported Outcomes) Module

Randomization Module

Medical Coding Module

Vendor Neutral Imaging Archive (VNA)

CTMS by SimpleTrials

IWRS & Inventory Management

Reporting Analytics Portal

Fully Customizable Data Review Status Work Flows

Fully Unified eClinical Suite

CDASH Compliant CRF Library

Vendor Neutral Imaging Archive (VNA)

Browser Based & Mobile Responsive

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

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

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.