Safety AI logo

Safety AI

by Datafoundry · Since 2016
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ActiveAvailable globallyCloud
Quick facts
VendorDatafoundry
Year launched2016
StatusActive
LocationNew Jersey 4105 US 1, Suite #16, Princeton, NJ, 08852
Countries servedGlobal
Languages1
IntegrationsN/A
Free tierNO
Free trialNO
Contact salesYES

About Safety AI

An AI-powered, cloud-based safety platform for the life sciences industry. It automates safety case management and signal detection for drugs, cosmetics, vaccines, nutraceuticals, and medical devices to ensure regulatory compliance and vigilance.

Datafoundry's Safety AI is a cloud-based safety management platform designed for the life sciences sector, including pharmaceuticals, cosmetics, and medical devices. It leverages AI and machine learning to automate and streamline pharmacovigilance processes. Key capabilities include AI-powered case intake from various sources, automated triage, signal detection, and literature monitoring. The platform is built to be compliant with industry standards like E2B R2/R3 and includes integrated MedDRA and WHO-DD browsers. It aims to significantly reduce manual effort, improve accuracy, and lower compliance costs for safety departments. The software is a modular, cloud-based solution. Pricing is not publicly available, and potential customers are directed to schedule a demo or contact sales. Support options are not detailed, but contact information for sales is provided.

Pros & Cons

Pros
  • Automates end-to-end pharmacovigilance, from case intake to submission.
  • Supports multiple life sciences domains including drugs, cosmetics, vaccines, and medical devices.
  • Designed to reduce manual effort by up to 70%, improving productivity and accuracy.
  • Cloud-based platform with flexible deployment options.
  • Built-in compliance with regulatory standards like E2B R2/R3.
Cons
  • Pricing information is not publicly available and requires contacting the vendor.
  • No free trial or free tier is mentioned on the website.
  • Specific details on customer support channels like live chat or a dedicated support portal are not provided.

Features

Key features

AI-Powered Case Intake

Automates safety case data collection from multiple sources, including documents and images.

Signal Detection and Risk Management

Utilizes an advanced signal detection engine for proactive safety monitoring.

Automated Literature Monitoring

Scans literature for safety information and adverse event monitoring.

E2B R2 & R3 Compliance

Features an enhanced, built-in E2B compliant data import and export for integration with other safety databases.

Automated Triage

Provides rule configuration for automated case triage, seriousness prediction, and causality assessment.

Auto Narrative Generation

Automatically generates case narratives to reduce manual effort.

Multi-Vigilance Support

Manages safety processes across pharmaceuticals, cosmetics, devices, and vaccines in a unified platform.

Additional features

Custom Report Generation

Allows for the creation of custom reports for analysis and regulatory needs.

Case Compliance Alerts

Provides alerts to ensure compliance with safety reporting timelines.

Integrated MedDRA and WHO-DD Browsers

Includes integrated medical dictionaries for standardized coding.

E-Submissions Gateway

Facilitates electronic submissions to regulatory authorities.

Product and Study Configuration

Allows for detailed configuration of study and product information.

Bulk Data Migration

Supports the transfer of large amounts of case data using XML.

Expectedness and Listedness Assessment

Automates the assessment of adverse events against product information.

Pricing

Free trial
Free version
Request a quote
Promo Offer

Countries & Languages

Global
Countries served
1
Interface languages
1
Billing currencies

Interface languages

English

Billing currencies

🇺🇸USD

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