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features
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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

SAP Store No 

Integrations

SAP Store Yes 

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 

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