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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
eDeviation provides comprehensive tools for assessing and managing Protocol Deviations. It streamlines processes from software design and validation to gathering necessary documentation and exporting information for the Trial Master File (TMF), thereby alleviating the burden on clinical teams who may face risks from improperly assessed or overlooked protocol deviations, whether they occur once or multiple times. As a component of Ethical's eClinical Software Platforms, eDeviation® enhances the efficiency and accuracy of clinical trial management. Whether evaluations are conducted by a dedicated independent committee or by your own research team, our software can be tailored to meet your specific requirements. The integration of forms, workflows, and export functions ensures adherence to GxP standards and fosters effective study management. Additionally, this platform allows study teams, investigators’ sites, and committee members to collaborate online in real-time, facilitating quicker decision-making, reaching consensus, and ensuring the prompt handling of protocol deviation assessments and management. Ultimately, eDeviation® enhances the overall integrity and efficiency of clinical trial processes, contributing to better outcomes in research.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
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
eDeviation
Website
www.protocoldeviation.com/eDeviation-software
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