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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.

What is RegDoc eSafe?

Introducing an eReg platform designed specifically for study sites, this solution guarantees swift setup without enforcing strict workflows, featuring a user-friendly interface and capabilities. You can try RegDoc eSafe at no cost today! This platform serves as a secure repository for source documents and comes with tools that enable the transfer, redaction, and assignment of time-limited, role-based access to sensitive data. RegDoc eSafe offers rapid and adaptable configuration options, requires little training for easy navigation, and includes a thorough yet efficient validation procedure. The implementation process is streamlined to quickly ready your clinical study sites for operation, and regulatory binder templates are conveniently accessible within your site for easy retrieval. The platform supports user uploads and has access control settings, supplemented by dedicated training sessions for both administrators and users. MedPoint emphasizes compliance, assisting you in all necessary steps to validate our software successfully. With extensive experience in developing and maintaining validated systems, MedPoint is subject to regular audits by study sponsors, which ensures the highest reliability and quality in our services. Our ongoing commitment to improvement and user satisfaction not only distinguishes us in the industry but also reinforces our dedication to providing exceptional support. Furthermore, we continuously seek feedback from our users to enhance the platform further, ensuring that it meets evolving needs in the field.

Media

Media

Integrations Supported

Crow Canyon Contract Management

Integrations Supported

API Availability

API Availability

Pricing Information

Per user, Per month

Pricing Information

Contact MedPoint Digital for pricing details.

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

Court Square Group

Date Founded

1995

Company Location

United States

Company Website

www.regdocs365.com

Company Facts

Organization Name

MedPoint Digital

Company Location

United States

Company Website

www.medpt.com/site-services/

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

Categories and Features

Document Control

Not specified

Document Management

Compliance Tracking
Document Archiving
Version Control

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