Reportum Platform by Qinecsa

Reportum® is a unified safety intake and pharmacovigilance reporting platform developed by Qinecsa, designed to capture adverse events at source and streamline the generation, management, and delivery of safety reports across global regulatory environments. It serves pharmaceutical companies, biotechs, and health authorities that need to manage growing adverse event volumes across multiple reporting channels while maintaining compliance and data quality at scale.

As reporting channels and data volumes increase, pharmacovigilance teams face fragmented processes, manual inefficiencies, and difficulty maintaining oversight across global stakeholders. Reportum addresses these challenges by providing a structured, technology-enabled framework that integrates data, processes, and expertise into a single platform, supporting both digital and analogue intake channels and covering regulatory requirements in markets including the EU, UK, and US.

Safety Intake Capabilities

• Captures adverse events at source across multiple digital and analogue channels, reducing reliance on manual data entry
• Standardises intake processes across global stakeholders to improve consistency and data quality
• Reduces manual effort involved in collecting and processing safety data
• Supports pharmacovigilance teams in scaling reporting operations without proportional increases in manual workload

Safety Reporting and Workflow Management

• Supports the generation of periodic and aggregate safety reports, including PSURs, PBRERs, DSURs, and signal-related reports
• Manages complex reporting timelines and multi-stakeholder workflows within a single structured environment
• Provides traceability and governance controls expected by global regulators
• Strengthens workflow control and operational visibility across reporting activities
• Helps maintain quality and accuracy throughout the report production process

Compliance and Operational Oversight

• Designed to meet regional regulatory expectations across major markets including the EU, UK, and US
• Reduces the likelihood of inconsistencies and delays associated with manual or disconnected reporting processes
• Gives pharmacovigilance leaders greater visibility and control over reporting activities
• Supports patient safety objectives by improving the reliability and efficiency of adverse event reporting

Reportum is positioned as a platform for life sciences organisations that need to manage pharmacovigilance reporting at scale, combining intake standardisation, structured reporting workflows, and compliance controls within a unified solution.