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Average Ratings 0 Ratings

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ease
features
design
support

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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

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

SAP Store

Integrations

SAP Store

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
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

SyMetric Systems

Founded

2012

Country

India

Website

symetricsystems.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

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