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Description
NewTn's SAFETY is a cutting-edge cloud platform for pharmacovigilance that aims to streamline safety processes and ease compliance for pharmaceutical companies, emerging startups, and contract research organizations. This solution presents a wide array of features, such as scalable cloud infrastructure for enhanced data storage and processing, the ability to reuse data to avoid repetitive entries, real-time alerts and monitoring to swiftly detect adverse reactions, and strong reporting capabilities that aid in creating DSUR and PBRER reports. Specific use cases demonstrate its value in building pharmaceutical safety databases for new companies, offering budget-friendly safety solutions for cost-conscious CROs, improving regulatory adherence for small and medium-sized pharmaceutical firms, and providing thorough safety data analysis and reporting. The platform is distinguished by its user-friendly interface and experience, along with its specialized support for DSUR and PBRER reporting, making it a versatile and customized solution for various stakeholders in the pharmaceutical industry. Moreover, NewTn's SAFETY ensures that all users can effectively navigate the complexities of safety management with confidence and ease.
Description
adWATCH - AE is a solution designed to aid pharmaceutical companies in handling and documenting adverse events that arise during clinical trials. It provides a quick and efficient way for reporters at clinics, hospitals, or investigative sites to create and oversee Adverse Event Reports (AERs), ensuring proper reporting to regulatory bodies and government organizations. An adverse effect refers to a harmful or undesirable reaction experienced by a patient due to medications or medical devices. The process of documenting adverse events necessitates thorough tracking of all medical complaint case details, which culminates in the creation of MedWatch reports, CIOMS reports, and other management documentation. With adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), clinical trial experts, and various health professionals can easily generate and submit AERs in compliance with FDA requirements, adhering to both MedWatch and CIOMS formats. This streamlined process not only enhances regulatory compliance but also improves patient safety oversight during clinical trials.
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
NewTn-SAFETY
Country
United States
Website
safety.newtn.life/
Vendor Details
Company Name
Atlant Systems
Website
atlantsystems.com/atlant/solutions/atwatch-ae/
Product Features
Product Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management