RegDocs365

RegDocs365

Court Square Group
TrialKit

TrialKit

Crucial Data Solutions
+
+

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About

Out-of-the-box, scalable, real-time collaborative solution for CRO’s, Life Science Consultants, Regulatory Groups and Industry Stakeholders. Built in an Audit Ready Compliant Cloud (ARCC) environment. Meets all 21 CFR Part 11 requirements. GxP audit ready. Pre-configured Departmental. Internal/External stakeholder communications. Secure data integration across remote teams. Collaborative review and approval workflow. Turn access on/off as needed (EX: auditors, reducing audit prep time to hours vs days). Preconfigured to EDM & eTMF Reference Models. Improve workflows through intelligent content management tools. Unify and improve the document management lifecycle with real-time collaboration, automatic indexing, and co-authoring capabilities. Pre-configured validated system that easily manages documents and data electronically that complies with eCTD mandates.

About

TrialKit is a unified eClinical platform for sponsors, CROs, and research institutions, combining EDC, ePRO/eCOA, eSource, eConsent, RTSM, eTMF, medical coding, imaging, and more in one environment. Floyd, TrialKit's AI model, works directly within the platform to support protocol interpretation, study building, validation, simulation, and analysis. It can generate eCRFs, visit schedules, edit checks, and workflows, while synthetic participants help teams test study configurations. Researchers retain control over reviewing and refining study designs. Web and native mobile apps support data collection across traditional, hybrid, and decentralized studies. Open REST APIs enable integration with external systems, while audit trails and role-based access support study oversight. TrialKit also offers predictable monthly platform pricing without incremental change-order fees for routine study modifications.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Audience

Pharmaceutical, biotech, life science, medical device vendors, and more

Audience

Sponsors and CROs seeking smarter, more scalable technology to support their studies.

Support

Phone Support Supported
24/7 Live Support Supported
Online Not Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Per user, Per month
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Court Square Group
Founded: 1995
United States
www.regdocs365.com

Company Information

Crucial Data Solutions
Founded: 2010
United States
www.crucialdatasolutions.com

Alternatives

Alternatives

Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
cubeCTMS

cubeCTMS

CRScube
Track.Health

Track.Health

Pryzm Health
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru

Categories

Categories

DICOM Viewers Supported
Medical Coding Supported
PACS Supported

Clinical Trial Management Features

21 CFR Part 11 Compliance Supported
Document Management Supported
Electronic Data Capture Supported
Enrollment Management Not Supported
HIPAA Compliant Supported
Monitoring Not Supported
Patient Database Not Supported
Recruiting Management Not Supported
Scheduling Not Supported
Study Planning Not Supported

Clinical Trial Management Features

21 CFR Part 11 Compliance Supported
Document Management Supported
Electronic Data Capture Supported
Enrollment Management Supported
HIPAA Compliant Supported
Monitoring Supported
Patient Database Not Supported
Recruiting Management Not Supported
Scheduling Supported
Study Planning Supported

Electronic Data Capture Features

Audit Trail Supported
CRF Tracking Supported
Data Entry Supported
Data Verification Supported
Distributed Capture Supported
Document Imaging Supported
Document Indexing Supported
Forms Management Supported
Remote Capture Supported
Study Management Supported

Integrations

Crow Canyon Contract Management Supported

Integrations

Crow Canyon Contract Management Not Supported
Claim RegDocs365 and update features and information
Claim RegDocs365 and update features and information
Claim TrialKit and update features and information
Claim TrialKit and update features and information