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Description
Orbit is a comprehensive platform geared towards improving patient safety by aiding biopharma companies of all sizes in expanding their safety operations across international markets. This platform provides cutting-edge solutions for global pharmacovigilance, safety management, and risk oversight, with the goal of enhancing overall quality, ensuring compliance, boosting productivity and efficiency, and offering significant oversight of processes that are often complex and compartmentalized. Among its essential features are risk management and minimization, which facilitate the monitoring of commitments within global risk management plans while also supporting the implementation of local risk mitigation measures; management of safety data exchange and pharmacovigilance agreements, which enables effective oversight of global collaborations; as well as signal and surveillance management, which encompasses everything from strategy planning to detection activities, signal evaluation, and ongoing tracking. Additionally, Orbit’s user-friendly interface ensures that teams can easily navigate the platform and utilize its features to their fullest potential.
Description
PvEdge is a state-of-the-art cloud-based pharmacovigilance software crafted to deliver comprehensive and compliant safety solutions for pharmaceuticals, medical devices, vaccines, and their combinations. It features an all-encompassing safety database that streamlines the management of pharmacovigilance intake, case processing, submissions, AI-driven analytics, and safety signal detection within a single user-friendly interface. This platform is designed to meet both current and forthcoming regulatory standards, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR, thus ensuring worldwide compliance. By harnessing the power of advanced automation through AI and machine learning technologies, PvEdge significantly boosts the efficiency of drug safety database management. Notable functionalities encompass automated literature review, expedited ICSR submissions, intelligent triage processes, automated signal detection, and streamlined document automation. Additionally, the system incorporates a controlled document management feature that facilitates the creation, oversight, and dissemination of essential pharmacovigilance documentation, alongside a risk-based enterprise quality management framework aimed at establishing robust quality control processes and maintaining meticulous training records. Through these diverse capabilities, PvEdge stands out as an invaluable tool for organizations committed to upholding the highest standards in drug safety.
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
No
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
No
Mac
No
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)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Orbit
Founded
2012
Country
United States
Website
www.workinorbit.com
Vendor Details
Company Name
Sarjen Systems
Founded
1998
Country
India
Website
pvedge.sarjen.com