Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
Integrations
cubeCTMS
No
cubeSAFETY
No
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