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

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

Meet with Christopher Kata at the”6th Annual Clinical Operations in Oncology Trials West Coast” on April 30th & May 1st 2019

March 18, 2019

Meet with Christopher Kata, Director of Sales & Marketing on April 30th & May 1st 2019 at the 6th Annual Clinical Operations in Oncology Trials! Christopher Kata, Director of Sales & Marketing905 999-1957ckata@trialstat.com When: April 30th & May 1st 2019 at 7:45 am – 5:00 pm Where: Burlingame, California Registration: http://www.arena-international.com/oncologywestcoast 6th Annual Clinical Operations in Oncology Trials…

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Meet with Christopher Kata at “Outsourcing in Clinical Trials South East” on March 26th & 27th in North Carolina

March 1, 2019

Meet with Christopher Kata, Director of Sales & Marketing on March 26th & 27th 2019 at Outsourcing in Clinical Trials South East in North Carolina ! Christopher Kata, Director of Sales & Marketing 905 999-1957 ckata@trialstat.com When: March 26th & 27th 2019 Where: Sheraton Imperial Hotel and Convention Center, 4700 Emperor Blvd, Durham, NC 27703. Registration:…

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TrialStat invites clinical operations leaders and researchers to join them at this year’s SCOPE Summit to explore the latest advances in data management technology

February 17, 2019

Montreal-based TrialStat Solutions Inc., a trusted provider of eClinical technology solutions, will be exhibiting at this year’s Summit for Clinical Operations Executives (SCOPE) in Orlando, FL from February 18-21. Christopher Kata, Director, Sales and Marketing, will be conducting demonstrations of TrialStat’s flexible, leading-edge technology built for the needs of today’s life sciences companies. Join Christopher…

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Meet with Christopher Kata at “Outsourcing in Clinical Trials West Coast” on February 12th & 13th

January 28, 2019

Meet with Christopher Kata, Director of Sales & Marketing on February 12th & 13th 2019 at Outsourcing in Clinical Trials West Coast ! Christopher Kata, Director of Sales & Marketing 905 999-1957 ckata@trialstat.com When: February 12th & 13th 2019 at 7:30 am – 5:40 pm Where: Hyatt Regency San Francisco Airport Hotel, 1333 Bayshore Highway, Burlingame,…

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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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