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
As a provider specializing in Data Management, we deliver comprehensive services that include both data management and the planning and development of statistical analyses alongside suitable CRF design. We ensure that all necessary documentation complies with FDA standards and other relevant regulations. Our previous experiences indicate that investing more time in the planning stage significantly enhances the overall efficiency and speed of the trial's final phases. Our databases are meticulously created by seasoned data managers who possess extensive knowledge of various eCRFs and understand the essential aspects of electronic data capture system design and data collection. This expertise enables us to construct the eCRF in a remarkably short timeframe. Additionally, the validation and testing of the eCRF are critical components of our design process, handled by separate personnel to guarantee a thoroughly detailed and functional eCRF. By prioritizing these elements, we can ensure the highest quality outcomes for our clients.
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
Quretec
Founded
2006
Country
Estonia
Website
www.quretec.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
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
Yes
CRF Tracking
Yes
Data Entry
Yes
Data Verification
Yes
Distributed Capture
Yes
Document Imaging
Yes
Document Indexing
No
Forms Management
No
Remote Capture
Yes
Study Management
Yes