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features
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support

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Description

ProcEdge Regulatory Information Management System (RIMS) provides companies with a powerful, centralized platform to manage complex regulatory requirements for their entire global product portfolio. Moving away from traditional Excel-based tracking, it offers a single source of truth that connects multiple departments, providing 360-degree visibility and real-time updates on product registration, license maintenance, and post-registration activities. The platform enables detailed planning and tracking of submission timelines tailored to country-specific regulations, helping users meet compliance standards and reduce costly errors. It features configurable data models, automated email notifications, and a robust workflow engine that streamlines query management and response tracking. ProcEdge RIMS complies with global standards like IDMP and regulatory frameworks including GxP, GDPR, and Part 11. By eliminating redundant systems and manual data entry, it significantly reduces operational expenses and accelerates health agency approvals. The system’s audit trails and electronic signature capabilities ensure data integrity and regulatory reliability. Overall, it empowers regulatory professionals to make faster, informed decisions and maintain product marketability efficiently.

Description

cubeSAFETY is an advanced pharmacovigilance platform designed to assist safety teams in efficiently managing adverse-event reporting, regulatory submissions, and case processing in a compliant manner. It adheres to ICH E2B and various regional reporting standards, facilitating submissions to agencies like the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, while also automatically converting and formatting data for CIOMS and XML export. The platform boasts AI-driven medical coding suggestions, duplication detection, the capability to import CIOMS PDF files, and dynamic dashboards for real-time submission tracking. Additionally, it offers complete integration with other CRScube modules, including cubeCDMS. cubeSAFETY is crafted to enhance the safety-case entry process, guarantee superior data quality through embedded validation features, and streamline workflows for compliance with global regulatory requirements, all while decreasing manual labor and financial overhead. Ultimately, this innovative platform aims to redefine pharmacovigilance efficiency and accuracy across the industry.

API Access

Has API

API Access

Has API

Screenshots View All

No images available

Screenshots View All

Integrations

XML
cubeCDMS
cubeCTMS

Integrations

XML
cubeCDMS
cubeCTMS

Pricing Details

$300
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

Sarjen Systems Pvt Ltd

Founded

1998

Country

India

Website

rims.sarjen.com

Vendor Details

Company Name

CRScube

Founded

2010

Country

South Korea

Website

www.crscube.io/solution/cubesafety

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