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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
We provide a range of solutions, from straightforward turnkey options to extensive multi-site research projects, assisting principal investigators in navigating the typical challenges associated with database configuration and selection. Researchers frequently turn to QuesGen for expert guidance on optimal data management practices and for supplementary services that facilitate the swift launch of their studies. As a seasoned collaborator for numerous academic institutions and researchers, we excel in handling sizable datasets and performing data curation through our adaptable data platform. This capability allows for the rapid and seamless initiation and expansion of research projects. With an all-encompassing data model, a library of assessments, and expertise in curation, QuesGen is dedicated to ensuring that you are operational quickly while guaranteeing high-quality, compliant data, enabling you to concentrate on analyzing your findings. Our solutions support various clinical research efforts within your organization, adhering to HIPAA and FDA 21 CFR Part 11 requirements, and they can seamlessly integrate with your electronic medical records system and the Federal Interagency TBI Repository (FITBIR). By leveraging our services, researchers can enhance their efficiency and streamline their workflows, ultimately leading to more impactful research outcomes.
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
$100 per month
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
QuesGen Systems
Founded
2004
Country
United States
Website
www.quesgen.com
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