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

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.

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

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

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

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The Proposed New FDA Rule Brings Changes To Informed Consent for Clinical Studies

November 23, 2018

The Diagnostic and Interventional Cardiology website posted an important article about recent proposed changes by the FDA which may allow Institutional Review Boards (IRB) to waive or alter informed consent requirements for clinical studies that pose minimal risk to human participants. The conditions under which an IRB could do this are limited and detailed in the…

Meet with Christopher Kata at DeviceTalks West 2018 December 11th & 12th!

November 19, 2018

Meet with Christopher Kata, Director of Sales & Marketing on December 11th & 12th 2018 DEVICETALKS West ! Christopher Kata, Director of Sales & Marketing 905 999-1957 ckata@trialstat.com When: December 11th & 12th 9:00 am – 5:30 pm Where: HILTON ORANGE COUNTY / COSTA MESA, 3050 Bristol St, Costa Mesa, CA 92626 Registration: https://west.devicetalks.com/      …

Meet With Christopher Kata at the “Talking to Doctors & Patients: Using Primary Market Research Data to Seal the Deal with Investors” Event on November 13th!

November 5, 2018

Meet with Christopher Kata, Director of Sales & Marketing on November 13th at the OBIO Event “Talking to Doctors & Patients: Using Primary Market Research Data to Seal the Deal with Investors”! Christopher Kata, Director of Sales & Marketing 905 999-1957 ckata@trialstat.com When: November 13th 11:00 am – 2:00 pm Where: 100 College St Suite 150…

Meet with Christopher Kata at the SoCalBio Digital Health Conference November 9th!

October 30, 2018

Meet with Christopher Kata, Director of Sales & Marketing on November 9th at the SoCalBio Digital Health Conference! Christopher Kata, Director of Sales & Marketing 905 999-1957 ckata@trialstat.com When: November 9th 8:00 am – 6:30 pm Where: Hotel Maya 700 Queensway Dr, Long Beach, CA 90802 Registration: https://socalbio.org/socalbio-digital-health-confernce/       SoCalBio Digital Health Conference The…

You're Going to be Amazed By TrialStat

With TrialStat your studies will run smoothly, on-time and within budget.

Your Study Coordinators will enjoy the intuitive user interface and the speed in which they can enter their data. Schedule your personalized demo today to see first hand how TrialStat will transform your studies!

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