In the clinical development and post marketing of medicinal products or new drugs there is always a potential risk of adverse events or side effects. An efficient reporting system lets you react and comply with the authorities’ demands for timely reporting.

NNIT offers a number of safety systems including Oracle Argus, a configuration-based pharmacovigilance safety suite that provides complete case management and regulatory reporting functionality. We have the necessary business knowledge and process experience within pharmaceutical development to help you decide upon the best solution for your organisation as well as the technical capabilities to ensure seamless integration with your existing systems and SOPs.

Our pharmacovigilance solutions offer a range of benefits including:

• Information supply chains that integrate ad hoc requests
• CDMS safety systems reconciliation
• DMC information supply
• Coordination of safety committees
• Reporting to authorities
• Integration with other medical information systems
• SDR reporting
• Metrics development and updates