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features
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support

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Write a Review

Description

PharmaPendium serves as a robust platform that grants users access to a wide array of FDA and EMA drug approval documents, encompassing essential aspects like pharmacokinetics, pharmacodynamics, and safety evaluations. This resource delivers in-depth insights into drug-drug interactions, side effects, and outcomes from clinical studies, thereby empowering stakeholders to make well-informed decisions during the drug development process and when making regulatory submissions. Its rich database aids researchers and healthcare practitioners in assessing both the efficacy and safety of medications, playing a pivotal role in the progression of pharmaceutical research and enhancing patient care. Users can explore historical regulatory submissions and leverage past precedents to better understand and anticipate agency requirements. The interface allows for a seamless transition from tabular data to dynamic charts, graphs, and other visual tools, making it easier to analyze and interpret findings. Additionally, users can search for information related to adverse events (MedDRA), therapeutic targets, drug indications, and endpoints utilizing standardized data. Result pages effectively connect preclinical research with clinical applications, facilitating a comprehensive understanding of the drug development landscape. Overall, this platform not only streamlines the research process but also fosters collaboration and knowledge-sharing among industry professionals.

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

Screenshots View All

Integrations

XML
cubeCDMS
cubeCTMS

Integrations

XML
cubeCDMS
cubeCTMS

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

Elsevier

Founded

1880

Country

Netherlands

Website

www.elsevier.com/products/pharmapendium

Vendor Details

Company Name

CRScube

Founded

2010

Country

South Korea

Website

www.crscube.io/solution/cubesafety

Product Features

Product Features

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