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
Through the use of the eAdjudication® software managed service, trial leaders can effectively oversee timelines, adapt to fluctuating circumstances and results, and track trends in provider performance and adherence to protocols throughout the extended duration of trials. This innovative, comprehensive managed software service helps prevent unforeseen expenses and timeline violations in Endpoint Adjudication Studies. The eAdjudication® Managed Software Service stands out as the most effective solution for managing Endpoint Adjudication (CEC). By collaborating with the eAdjudication® platform and Ethical's staff, study teams, committee members, and clinical organizations can engage seamlessly in real-time within a user-friendly and GxP-compliant framework, eliminating the inefficiencies, costs, and errors associated with manual processes. Furthermore, the all-inclusive nature of eAdjudication® services facilitates the smooth integration and adoption of EA software across eClinical organizations, enhancing overall operational efficiency. In doing so, it empowers research teams to focus on delivering quality results without being hindered by logistical challenges.
API Access
Has API
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
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
Ethical
Founded
2013
Country
Switzerland
Website
www.endpointadjudication.com
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
Yes
Document Management
No
Electronic Data Capture
Yes
Enrollment Management
No
HIPAA Compliant
No
Monitoring
Yes
Patient Database
No
Recruiting Management
No
Scheduling
No
Study Planning
Yes