Genira has developed PV.app, an AI-powered cloud solution that streamlines pharmacovigilance case intake for pharmaceutical companies, biotechs, and CROs, significantly increasing reporting rates and enhancing safety compliance. By automating data collection and analysis while adhering to international standards, PV.app reduces manual workload and provides validated data for regulatory submissions.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical companies, biotechs, and CROs face challenges in efficiently managing and processing the high volume of pharmacovigilance case reports required for regulatory compliance. Manual data entry, disparate systems, and inconsistent data validation lead to increased workload, potential errors, and delays in regulatory submissions.
Solution
PV.app is an AI-powered cloud solution designed to streamline pharmacovigilance case intake and reporting, improving data quality and regulatory compliance. The platform automates data collection from various sources, including paper-based forms and mobile apps, and integrates with existing pharmacovigilance databases. By applying AI-driven validation and standardization, PV.app ensures data accuracy and reduces the manual effort required for case processing. The system supports ICH E2B R3, MedDRA, and WHODrug standards, facilitating the generation of XML, CIOMS, and PDF reports for regulatory submissions. PV.app offers a unified solution for managing safety case intake, enhancing collaboration between pharmaceutical companies, healthcare professionals, and patients.
Target Audience
The primary target audience includes pharmaceutical companies, biotechnology firms, contract research organizations (CROs), and regulatory agencies involved in pharmacovigilance and drug safety reporting.
Features
- AI-powered data extraction and validation to minimize manual data entry errors
- Support for multiple reporting channels, including paper forms, mobile apps, and direct submissions from healthcare providers
- Compatibility with common pharmacovigilance databases for seamless data integration
- Automated generation of regulatory-compliant reports in XML, CIOMS, and PDF formats
- Multidevice support, allowing users to start and continue work on different devices
- Offline reporting capabilities for data collection in areas with limited internet connectivity
- Configurable activity and feedback notifications for new ICSRs and AE assessment results
- Embedded hint system providing tips and guidance for completing each field in the reporting form
- Redundant cloud storage with audit trails and backups to ensure data security and integrity
- GAMP5 validation and compliance with GxP and 21 CFR Part 11 (Annex 11)