TrialStat EDC

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

TrialStat's Interoperable eClinical Suite

Explore TrialStat's eClinical Suite with our Interactive Infographic

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 Simple to Complex 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.

EDC + eConsent + ePRO + Randomization + Coding

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 eConsent

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

TrialStat's eConsent is fully integrated with TrialStat's EDC or it can be used with other EDC platforms!

Explore TrialStat eConsent

Contact us today to find out more about the eConsent module and see how it works!

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?

See What Our Clients Are Saying About TrialStat

Plus Therapeutics found a reliable, scalable partner in TrialStat Solutions as we transition from manual processes. Their unified eClinical suite simplifies data collection, provides real-time insights, and offers modular features and functions that will allow us to expand into their cost-effective system as we grow. Their dedication to innovation and customer satisfaction is crucial to our success and we highly recommend them.

- Norman LaFrance, Chief Medical Officer, SVP, Plus Therapeutics

“Dear Heather and Jeff,

I hope this email finds you both well. On behalf of the Plus Therapeutics team, I am grateful to both of you for hosting the exceptional onboarding EDC training for the Plus Therapeutics team and our site staff yesterday. Your expertise and dedication truly shone through, and it was a fantastic learning experience for all of us.”

-Rosemary Afful, Senior Clinical Research Associate, Plus Therapeutics

“If you ask the TrialStat team a question, the answer is never “No”, but “let’s see how we can accomplish that!”

- Colin Miller, CEO, The Bracken Group

The knowledgeable team at TrialStat worked with us to develop a validated custom web application, integrated with both EDC and our internal systems, that streamlines workflow and maximizes our team’s productivity. We can collect and manage trial data in a more timely and efficient manner now, which makes our clients happy too.

- Judi Hall, VP Clinical Research at Alimentiv

"TrialStat surpassed our expectations with their exceptional customer service and intuitive EDC Platform. Their personalized support and expert guidance made navigating the critical tasks of customizing the eCRFs and data migrations in our complex studies, remarkably straightforward and easier! Compared to other platforms we considered, TrialStat's tailored approach and unwavering timely assistance have been instrumental in the successful execution and conduct of our trials."

- Conroy Campbell, Director of IT, Plus Therapeutics

Explore TrialStat's comprehensive eClinical Suite

EDC-Infographic Small

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

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.

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

Recent News, Updates & Announcements

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

Repare Therapeutics Doses First Patient in Phase 1 Clinical Trial of RP-1664

February 21, 2024

RP-1664 is a Potential First-in-Class, Selective, PLK4 Inhibitor Excerpt from the Press Release: CAMBRIDGE, Mass. & MONTREAL–(BUSINESS WIRE)–Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced the first patient has been dosed in the Company’s Phase 1 LIONS (PLK4 Inhibitor in Advanced Solid Tumors) clinical trial evaluating…

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Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for its Phase 1 Trial of PAS-004

February 20, 2024

— Activation of four U.S. sites for Phase 1 clinical trial of PAS-004 to evaluate safety, dose, key biomarker data and preliminary efficacy — — Plans to open three additional sites in Eastern Europe in the coming months — — Preliminary interim data expected in 2H 2024 — Excerpt from the Press Release: SOUTH SAN…

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Carrick Therapeutics Announces First Patient Dosed in Phase 1b/2 Clinical Trial of Samuraciclib in Combination with Vepdegestrant in Patients with Advanced Breast Cancer

February 19, 2024

Excerpt from the Press Release: BOSTON, Feb. 14, 2024 (GLOBE NEWSWIRE) — Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 1b/2 clinical trial evaluating the combination of samuraciclib (CT7001), an investigational oral and first-in-class inhibitor of CDK7, and vepdegestrant…

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