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Average Ratings 0 Ratings

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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

cubeCTMS No 
cubeSAFETY No 

Integrations

cubeCTMS Yes 
cubeSAFETY Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

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 Yes 
Document Management Yes 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant Yes 
Monitoring Yes 
Patient Database Yes 
Recruiting Management No 
Scheduling Yes 
Study Planning Yes 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Electronic Data Capture

Audit Trail No 
CRF Tracking No 
Data Entry No 
Data Verification No 
Distributed Capture No 
Document Imaging No 
Document Indexing No 
Forms Management No 
Remote Capture No 
Study Management No 

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