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What is NewTn-SAFETY?

NewTn's SAFETY is an innovative cloud-based platform designed for pharmacovigilance, focused on simplifying safety processes and ensuring compliance for pharmaceutical enterprises, emerging startups, and contract research organizations. This advanced solution offers a diverse range of features, including a scalable cloud infrastructure that enhances data storage and processing capabilities, the functionality to reuse data to minimize redundant entries, and real-time alerts and monitoring systems for the prompt identification of adverse reactions. Additionally, it provides robust reporting tools that facilitate the creation of essential documents such as DSUR and PBRER reports. Various practical applications underscore its importance in developing safety databases for new pharmaceutical companies, delivering cost-effective safety solutions for budget-minded CROs, enhancing regulatory compliance for small and mid-sized pharmaceutical entities, and offering comprehensive analysis and reporting of safety data. The platform stands out due to its intuitive user interface and experience, along with tailored support specifically for DSUR and PBRER reporting, making it a flexible and personalized option for different participants in the pharmaceutical sector. Furthermore, NewTn's SAFETY empowers all users to adeptly navigate the complexities associated with safety management, ensuring they do so with both confidence and ease, ultimately contributing to improved patient safety outcomes.

What is DF mSignal AI?

DF mSignal serves as a flexible and scalable system for the management of safety signals, significantly improving the effectiveness of risk management and signal detection within the pharmaceutical and medical device sectors, while also encompassing areas such as cosmetics and nutraceuticals. The platform offers both active and passive monitoring, featuring real-time monitoring of product-event combinations along with customizable clinical risk indicators and a user-friendly interface enriched by advanced analytics. It effortlessly integrates with MedDRA, WHO DD, clinicaltrial.gov, and various electronic data collection systems, delivering a holistic safety solution for industry professionals. Additionally, DF mSignal AI employs automation to calculate statistical scores, streamlining the signal detection process and enhancing accuracy. The system is meticulously designed to adhere to all relevant regulations, including 21 CFR Part 11, and incorporates stringent data privacy and integrity controls, as well as Good Practice guidelines (GxPs), to guarantee compliance and security for users. With its comprehensive features, DF mSignal not only optimizes safety signal management but also fosters confidence among stakeholders in the regulatory landscape.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

NewTn-SAFETY

Company Location

United States

Company Website

safety.newtn.life/

Company Facts

Organization Name

Datafoundry

Date Founded

2016

Company Location

India

Company Website

datafoundry.ai/m-signal/

Categories and Features

Pharmacovigilance

Not specified

Categories and Features

AI Manufacturing

Not specified

Pharmacovigilance

Not specified

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