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What is TrialKit?

TrialKit is a versatile cloud-based solution accessible through a web interface and a dedicated mobile application, designed to facilitate comprehensive clinical trial management for organizations involved in medical devices, diagnostics, digital therapeutics, and biopharmaceuticals, regardless of their scale. With our user-friendly study builder, you can create and launch validated studies in just days instead of weeks, eliminating the need for any programming knowledge. To date, numerous users worldwide have utilized the adaptability of TrialKit to successfully launch more than 8,000 studies spanning all stages of development. This platform empowers researchers to streamline their processes and enhance the efficiency of clinical research endeavors.

What is RegDocs365?

A comprehensive, adaptable, and real-time collaborative solution designed for Clinical Research Organizations, Life Science Advisors, and other industry participants is available seamlessly. This system is constructed within an Audit Ready Compliant Cloud (ARCC) environment, ensuring compliance with all 21 CFR Part 11 standards and GxP audit readiness. It features pre-configured departmental setups that facilitate communication with both internal and external stakeholders, enabling secure data integration for remote teams. The platform supports collaborative review and approval processes, allowing access to be toggled based on necessity (such as during audits), which significantly decreases audit preparation time from several days to mere hours. Additionally, it comes ready to align with eTMF Reference models and EDM, while intelligent content management capabilities enhance workflow efficiency. With real-time collaboration, automatic indexing, and co-authoring functionalities, document management becomes more streamlined. This validated system is specifically designed to handle documents and data electronically, adhering to eCTD regulations, thereby ensuring that all stakeholders can operate effectively and efficiently. By embracing this technology, organizations can transform the way they manage and share vital documents in the life sciences sector.

Media

Media

Integrations Supported

Integrations Supported

Crow Canyon Contract Management

API Availability

Has API

API Availability

Pricing Information

Pricing not provided

Pricing Information

Per user, Per month

Supported Platforms

SaaS
Android
iPhone
iPad
Mac

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

Crucial Data Solutions

Date Founded

2010

Company Location

United States

Company Website

www.crucialdatasolutions.com

Company Facts

Organization Name

Court Square Group

Date Founded

1995

Company Location

United States

Company Website

www.regdocs365.com

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Scheduling
Study Planning

DICOM Viewers

Not specified

Electronic Data Capture

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

Medical Coding

Not specified

PACS

Not specified

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
HIPAA Compliant

Document Control

Not specified

Document Management

Not specified

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