RegDocs365

RegDocs365

Court Square Group
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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

​SimpleTrials is an on-demand, subscription-based Clinical Trial Management System (CTMS) designed for sponsors, Contract Research Organizations (CROs), and investigative sites. It offers a comprehensive suite of tools to effectively plan, manage, and track clinical study portfolios, including features such as site startup and subject tracking, document management with integrated electronic Trial Master File (eTMF), real-time study analytics, calendar and monitoring, custom fields and trackers, ad-hoc reporting, planning and milestones, site contracts and payments, and electronic visit reports. It supports compliance with 21 CFR Part 11 and provides a secure, validated environment for clinical trial data. Users can customize tracking views, integrate with various Electronic Data Capture (EDC) systems, and utilize built-in templates for consistent document management.

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

Audience

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

Audience

Clinical research coordinators and data managers requiring a tool to streamline clinical trial operations and ensure regulatory compliance

Support

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

Support

Phone Support Supported
24/7 Live Support Not 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

$849 per month
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 Not Supported
Live Online Supported
In Person Supported

Company Information

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

Company Information

SimpleTrials
Founded: 2008
United States
www.simpletrials.com

Alternatives

Alternatives

cubeCTMS

cubeCTMS

CRScube
Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
Cloudbyz CTMS

Cloudbyz CTMS

Cloudbyz
LifeSphere eTMF

LifeSphere eTMF

ArisGlobal
CTMS Master

CTMS Master

Anju Software
cubeCTMS

cubeCTMS

CRScube
Cloudbyz eTMF

Cloudbyz eTMF

Cloudbyz
Clienvo eTMF

Clienvo eTMF

Clinevo

Categories

Categories

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

Integrations

Crow Canyon Contract Management Supported
REDCap Not Supported

Integrations

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