TrialStat EDC

Fast, Compliant, Fully Unified – EDC + IWRS + ePRO + Coding

TrialStat Portal

Real-Time Data & Analytics | Make Study Decision Sooner

Don't Settle For Standard EDC Technology & Services

With TrialStat EDC you'll have your studies up and running quicker, capture your study data more efficiently with fewer errors and reduce your overall study costs.

TrialStat eClinical Suite - Powering Virtual Clinical Trials

TrialStat® delivers data solutions on-demand for pharmaceutical, biotechnology, medical device companies, Contract Research Organizations and Data Management companies. Our TrialStat eClinical Suite™ consists of three fully unified product offerings - EDC, Portal and CTMS. We stand alone in the industry with such an all-compassing suite of products for conducting clinical trials.

Supporting Our Partner's and Sponsor's COVID-19 Research

EDC + Portal + CTMS

Powerful Data Capture, Real-Time Reporting and Trial Management Functionality In a Single Unified Suite.

TrialStat EDC

TrialStat EDC is a scalable, hosted, Electronic Data Capture Suite for pilot / proof of concept studies, Phase I, II, III and IV studies. In addition, TrialStat EDC is an ideal choice for the unique requirements of Medical Device and Diagnostic studies. TrialStat EDC uses the latest technology, allowing all users complete system access via any web browser or mobile device. 

Explore TrialStat EDC

Visit the TrialStat EDC page to explore additional information and download the TrialStat EDC Overview.

TrialStat Portal

TrialStat Portal provides ultimate study management through real-time visualization of all of your study data. It seamlessly integrates with all TrialStat products, offering flexible, customizable user dashboards to view and drill down into your data. Portal enables you to make critical decisions quickly and efficiently, to continuously maintain control of your study.

Explore TrialStat Portal

Visit the TrialStat Portal page to explore additional information and download the TrialStat Portal Overview.

TrialStat CTMS

TrialStat CTMS seamlessly captures and reports real-time dynamic data from clinical operations and data management functions. A variety of customizable reports are available through easy-to-use reporting dashboards. Real-Time reporting in a user-friendly empowers clinical teams to make decisions quicker and act sooner.

Explore TrialStat CTMS

Visit the TrialStat CTMS page to explore additional information and download the TrialStat CTMS Overview.

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.

Premium Modules & Custom Development Services

A Fully Unified eClinical Suite Offering EDC functionality with Randomization (IWRS), Inventory Management, Medical Coding and ePRO in a single platform.

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.

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.

Medical Coding

TrialStat EDC enables Data Managers to utilize WhoDrug, MedDra, and Custom dictionaries directly within TrialStat EDC to conduct their coding activities. Simply choose the desired dictionary and version and apply it to a field within an eCRF.

Custom Development

TrialStat is unique in the industry, providing validated custom development services. 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 services to meet your unique requirements while ensuring compliance with all relevant regulatory requirements such as 21 CFR Part 11, HIPAA and Privacy Shield.

Tired of Hearing "No" All The Time?

Do you have requirements for your studies which other EDC platforms can't support?

Don't worry, at TrialStat we've developed our technology specifically for you. Our Expert Clinical Consultants and Software Developers will work with you to implement the features you need within our Validated eClinical Suite.

We're Hiring! Check Out Our Careers Page For Open Positions:

A Unified eClinical Suite Delivering Real-Time Data

Fully Unified eClinical Suite

Completely Customizable eCRFs

CDASH Compliant CRF Library

IWRS

Inventory Management

Payment Tracking

Patient Reported Outcomes (ePRO)

Browser Based & Mobile Responsive

CTMS

Comprehensive Edit Checks

Dynamic Skip Logic

AE / SAE tracking

Image Management

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. 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

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.

Recent News, Updates & Announcements

Things are happening! Check back often or subscribe to our RSS Feed.

Wyss Institute gets $16M to repurpose FDA-approved drugs for Covid-19

July 1, 2020

Excerpt from the article: “As the scientific community races toward potential treatments for Covid-19, the respiratory illness caused by the novel coronavirus that has now killed at least 116,000 Americans, researchers at Harvard’s Wyss Institute are partnering with institutions across the U.S. on a new project using old materials. The Wyss Institute has signed a…

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IncellDx Files Patent for CCL5/RANTES Utility as a Diagnostic, Prognostic, and Therapeutic Biomarker in COVID-19 and Other Cytokine Storm Conditions

June 30, 2020

Excerpt from the press release: “SAN FRANCISCO–(BUSINESS WIRE)–IncellDx announces the patent filing with the USPTO and the Pre-EUA with the FDA for CCL5/RANTES Utility as a Diagnostic, Prognostic, and Therapeutic Biomarker in COVID-19. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of a novel coronavirus disease 2019 (COVID-19), is now a global pandemic.…

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4 Ways to Adapt your Inspection Readiness Framework in a Post COVID-19 World

June 29, 2020

Excerpt from the article: “Although much has changed in the landscape of clinical trials because of COVID-19, the framework of inspection readiness planning and activities remains the same. It is however crucial to understand how the impacts of COVID-19 play a role in our preparation activities. Our recent Halloran Speaker Series, “Inspection Readiness Framework and…

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