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
The innovative IWRS facilitates a streamlined and organized drug distribution across various investigation sites, significantly minimizing drug wastage while also adeptly managing intricate randomization processes for both single-arm and extensive multi-arm, multi-center studies. Additionally, the SyMetric Platform's Dynamic Adaptive Randomization feature prevents covariate imbalances among participants, ensuring equitable Treatment Assignment regardless of the sample sizes involved. With the patient management capabilities on the SyMetric Platform, users can efficiently handle Subject Screening and Enrollment, manage Visits, dispense and receive Investigational Product (IP), execute Unblinding, and oversee Withdrawals and Completion processes. Moreover, the robust IP supply management tools embedded in the SyMetric Platform empower drug supply coordinators to maintain stringent control over the supplies dispatched to sites, allowing them to modify supply strategies based on the current treatment arms and updated ratios. This comprehensive approach not only enhances operational efficiency but also strengthens the integrity of clinical trial outcomes.
API Access
Has API
No
API Access
Has API
No
Integrations
SAP Store
No
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
No
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Atlant Systems
Founded
2010
Country
United States
Website
atlantsystems.com
Vendor Details
Company Name
SyMetric Systems
Founded
2012
Country
India
Website
symetricsystems.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
No
Enrollment Management
Yes
HIPAA Compliant
No
Monitoring
Yes
Patient Database
Yes
Recruiting Management
Yes
Scheduling
Yes
Study Planning
No