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.

COVID-19 Response

With strong corporate guidance, a high degree of caution in our business practices including moving staff to home offices, and well-informed advanced preparations, TrialStat is fully operational and will continue to support our Sponsors and Partners as our entire industry works to ensure the safety of participants, health care workers, and research teams along with the integrity of all studies and their data.

From the entire TrialStat team, we wish you and yours good health as our industry and our communities work together to navigate this outbreak over the coming weeks and months.

TrialStat eClinical Suite

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.

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 EDC, TrialStat Portal and TrialStat CTMS based on your specific study requirements.  You'll see first hand how the TrialStat 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.

HIPAA

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 EDC, TrialStat Portal and TrialStat CTMS based on your specific study requirements.  You'll see first hand how the TrialStat 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.

The Many Faces of AI in Clinical Trials

March 30, 2020

Excerpt from the article: “AI is being applied in several aspects for the clinical trial process today. From analyzing real-world data and scientific information to providing improved patient stratification and predictive outcomes, and assisting with different aspects of clinical trial operations. Here are some of the technologies using AI and machine learning in the clinical…

Read More

‘We’re racing against the clock’: Researchers test wearables as an early warning system for Covid-19

March 29, 2020

Excerpt from the article: “Researchers at two prominent California universities launched ambitious new studies this week to test whether wearables can serve as a sort of early-warning system for parts of the country not yet flooded with coronavirus cases. University of California, San Francisco, researchers are exploring whether an algorithm fed with data from Oura…

Read More

Prisma Health says it’s developed a way to make 1 ventilator work for 4 coronavirus patients

March 28, 2020

Excerpt from the article: “Prisma Health said Wednesday that it has developed a device that will allow one ventilator to be used on four patients suffering from the coronavirus. Ventilators are an important part of treating people suffering with the respiratory infection. And a shortage of ventilators has been a concern of health leaders dealing…

Read More