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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

XML No 
cubeCDMS No 
cubeCTMS No 

Integrations

XML Yes 
cubeCDMS Yes 
cubeCTMS Yes 

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) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
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

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

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Product Features

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