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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

Protocol Manager is instrumental for clinical operations in overseeing global trials across various phases of drug, device, biologic, and vaccine development. By implementing the necessary Standard Operating Procedures (SOPs), Protocol Manager ensures compliance with the FDA’s 21 CFR part 11 regulations. The platform utilizes Web Services technology to facilitate effortless and automatic integration with numerous widely-used EDC and IVRS solutions. For those systems that lack Web Services compatibility, an export/import mechanism is available for integration. This comprehensive tool features a powerful tracking system and database that effectively manages a wide range of trial information and metrics, enhancing overall operational efficiency. Additionally, it empowers organizations to maintain rigorous oversight throughout the trial process, ensuring data integrity and compliance at every stage.

Description

cubeCDMS is a comprehensive electronic data capture solution specifically crafted for the management of clinical trial operations, enhancing the entire data collection and oversight process. This advanced system encompasses complete data management workflows, featuring automatic detection of protocol violations, batch management of queries, and integrated risk-based monitoring that collectively contribute to heightened data integrity and operational effectiveness. With its user-friendly, no-code interface, study teams can effortlessly create electronic case report forms (eCRFs) from a library boasting over 55 pre-designed forms and edit checks, enabling swift database setups and minimizing start-up times. Tailored for ease of use, cubeCDMS facilitates single data entry that is automatically shared across various integrated CRScube modules, thereby decreasing redundancy and simplifying the reconciliation process. Moreover, it offers a range of additional advantages, such as AI-enhanced medical coding assistance, intuitive drag-and-drop form creation tools, support for multiple languages, and comprehensive audit trails along with tracking of change histories, ensuring transparency and reliability throughout the trial process. This innovative solution empowers clinical researchers to focus more on their studies while optimizing their data management practices.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

cubeCTMS
cubeSAFETY

Integrations

cubeCTMS
cubeSAFETY

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Atlant Systems

Founded

2010

Country

United States

Website

atlantsystems.com

Vendor Details

Company Name

CRScube

Founded

2010

Country

South Korea

Website

www.crscube.io/solution/cubecdms

Product Features

Clinical Trial Management

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

Product Features

Clinical Trial Management

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

Electronic Data Capture

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

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