Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Electronic source documents, known as eSource, replace traditional paper methods, streamline workflows, and minimize the likelihood of errors and omissions. BREEZE eSource transcends basic visit templates and scheduling functionalities. By aligning clinical contexts with regulatory and protocol requirements, along with study procedures, BREEZE eSource ensures users effectively capture all necessary data mandated by the protocol. The business rules within BREEZE guarantee that data collected are not only correct but also complete, precise, and compliant with relevant standards. Our team of clinical trial specialists creates tailored eSource documents specific to each study for review and approval prior to the trial's initiation, providing ongoing support and adjustments throughout the study duration. The individual modules integrate flawlessly, working in unison to enhance efficiency. The Cross-Module Action Multiplier further elevates functionality by predicting and automatically fulfilling supplementary tasks based on user inputs, such as automatically recording completed visits or procedures, which then updates invoicing and recalibrates scheduling effortlessly. This interconnected approach not only simplifies trial management but also enhances overall data integrity and operational effectiveness.
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.
API Access
Has API
No
API Access
Has API
No
Integrations
Lybra Assistant
No
iPublish Media
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
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
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
BREEZE CTMS
Country
United States
Website
www.breezectms.com
Vendor Details
Company Name
Atlant Systems
Founded
2010
Country
United States
Website
atlantsystems.com
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Yes
Document Management
Yes
Electronic Data Capture
Yes
Enrollment Management
No
HIPAA Compliant
No
Monitoring
No
Patient Database
No
Recruiting Management
No
Scheduling
Yes
Study Planning
No
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