TheraLyze provides an AI-powered SaaS platform for pharmacovigilance case processing, significantly reducing manual data entry time. The system automates data extraction and supports Human-in-the-Loop validation for GxP-compliant safety database integration. It offers both essential case processing features and a full enterprise platform with transparent AI reasoning.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmacovigilance case intake is traditionally a time-consuming, error-prone, and costly process, especially with the increasing volumes of safety data. Manual data entry and processing can lead to delays in identifying and reporting adverse events, potentially impacting patient safety and regulatory compliance.
Solution
TheraLyze.ai offers an AI-powered platform that automates case intake for pharmacovigilance, eliminating manual data entry and significantly reducing case processing time. The platform uses AI and natural language processing (NLP) to extract relevant safety information from unstructured data sources, such as PDFs, Word files, and images. It then structures the data into ICH-compliant E2B R3 XML format, ready for submission to any pharmacovigilance database. This enables pharmaceutical companies and CROs to streamline workflows, improve efficiency, and ensure regulatory compliance while focusing on high-value activities like risk assessment.
Target Audience
The primary customers are CROs and pharmaceutical companies involved in pharmacovigilance, specifically those seeking to automate case intake, reduce manual data entry, and improve compliance with regulatory requirements.
Features
- Automated case entry using NLP to extract event and medical information and populate safety fields
- Medical coding using MedDRA and WHO Drug dictionaries for adverse reactions, indications, and concomitant drugs
- Duplicate detection to identify duplicate AERs or case follow-ups efficiently
- Intuitive interface with confidence scores to guide users in verifying and validating safety data
- Omni-channel intake supporting multiple formats (text, PDF, XML, etc.) and intake channels (API, email, UI)
- Data security features to redact PHI and PII while maintaining compliance with GDPR and HIPAA
- Seamless integration with any pharmacovigilance database via E2B R3 endpoints
- Zero configuration required to support new source data file formats
- No customer data required to train the machine learning models