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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
SafetyEasy by EXTEDO is a robust software solution for managing pharmacovigilance and multivigilance, aimed at simplifying the handling of safety cases and vigilance information. It adheres to a wide range of drug safety regulations such as E2B(R3) and HL7 eMDR, while facilitating the necessary creation of regulatory documents including PSUR, PBRER, and DSUR. The software is equipped with features that optimize workflows through email alerts and online dashboards, allowing users to efficiently monitor project progress and adhere to submission timelines. Additionally, SafetyEasy features sophisticated tools like CasEasy AI, which leverages Natural Language Processing to streamline the automation of case creation, alongside a Business Intelligence module that offers an insightful 360° perspective on scientific data, thereby improving case evaluation and safety signal identification. This cloud-based platform is not only quick to deploy but also designed for ease of use, requiring very little training for effective operation. Furthermore, the integration of these advanced functionalities makes SafetyEasy an invaluable asset for organizations aiming to enhance their pharmacovigilance processes.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
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
EXTEDO
Founded
2003
Country
Germany
Website
www.extedo.com/software/pharmacovigilance-and-drug-safety
