Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
In recent years, the Life Sciences sector has incurred nearly $15 billion in fines and settlements related to compliance, underscoring the importance for firms to follow best practices in pharmaceuticals, medical devices, and biotechnology. Additionally, the way clinical trials are managed can greatly influence the timeline, scope, and financial resources allocated for the development of drugs or medical devices. Utilizing OpenText™ Clinical Trial Quality Management System (ctQMS) allows organizations to maintain compliance, lower record management expenses, and foster collaboration to implement best practices throughout the entire clinical trial lifecycle. This strategic approach not only enhances operational efficiency but also contributes to the overall success of product development initiatives.
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
Screenshots View All
No images available
Integrations
No details available.
Integrations
No details available.
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
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)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
OpenText
Founded
1991
Country
Canada
Website
www.opentext.com/info/clinical-trial-management
Vendor Details
Company Name
Atlant Systems
Founded
2010
Country
United States
Website
atlantsystems.com
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
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