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, IBM Clinical, Oracle DataTrack, Omnicomm and others, TrialStat is completely unique. TrialStat's eClinical Suite 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. More importantly, we provide named Project Management and Technical Support, custom pricing models, and custom validated development to provide you with a solution that fit's right in with your expectations.

Business team in the office

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].

Premium Modules and Capabilities

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

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

Accelerate clinical trial enrolment and maximize protocol compliance by leveraging TrialStat's comprehensive and immersive eConsent platform. Fully configurable workflows, including support for witnesses, assent, re-consent, and the ability for patients to revoke consent.

TrialStat's eConsent is fully integrated with TrialStat's EDC for added performance, but can be used with other EDC platforms if needed!

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

ePRO

Using our integrated Electronic Patient Reported Outcomes (ePRO) module, users can seamlessly combine site data with patient data without the need for a 3rd party system.

Using TrialStat ePRO eliminates the added cost of data reconciliation and integration with a 3rd party ePRO system. The ePRO module allows for full eCRF capabilities, localization of languages, customized patient interfaces and visit notification windows.

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

Medical Coding

Vendor Neutral Imaging Archive

In partnership with Fuji Film / Teramedica, we have integrated the Teramedica Vendor Neutral Imaging Archive (VNA) within the our Data Center.

TrialStat's VNA allows us to capture imaging at the site level, de identify the imaging / files, and route them to your core lab for review as well as enabling seamless imaging adjudication within your clinical trials.

Access your imaging in the VNA after the clinical trials have concluded, and take advantage of our integrated machine learning programs to generate maximum value from your imaging assets.

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

Clinical Data Warehouse

TrialStat goes beyond individual clinical trials by providing you and your teams with a Clinical Data Warehouse to store all of your current and past clinical trial data.

Perform meta analysis across studies, or tie into our bespoke Machine Learning Programs to extra the maximum value for your clinical trial data.

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

Machine Learning & AI

3rd Party Systems Integration

As a technology platform, TrialStat provides unparalleled interoperability allowing you to integrate data from a variety of sources including EMR/EHR systems, validated medical wearable devices, other EDC platforms, local and central labs and more. Data can also be seamlessly pushed into 3rd party systems such as CTMS software, eTMF software, safety systems and more.

Click on the diagram to your right to explore in more detail all of the capabilities available to you through our eClinical Suite.

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

Study Design and Validated Development

TrialStat also offers full service, flexible, cost-effective Study Development services across all phases of clinical research, as well as custom technology implementations and integrations. As a matter of practice, we regularly include new features based on Sponsor requirements.

Our expert Software Architects, Software Developers, and Compliance Experts provide complete custom development and technology integration services to meet your unique requirements while ensuring compliance with all relevant regulatory requirements such as 21 CFR Part 11, HIPAA and Privacy Shield.

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

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?

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

Download Corporate Overview

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.