How does Recordya help?

Recordya serves as a central platform that supports pharmacovigilance analysts in working with large volumes of clinical data and safety reports. The system automates the processing and retrieval of information from documents such as AE (Adverse Event) reports, PSURs, DSURs, and regulatory communications, providing rapid access to the most up-to-date and reliable data.

Thanks to its implementation of the Model Context Protocol (MCP), Recordya can integrate knowledge from multiple sources — including internal company repositories, external databases, CRM systems, and safety case management solutions.

This enables data analysis within a broader context, taking into account not only the content of a document but also its role and significance within the overall drug safety monitoring process.

The built-in semantic search engine understands the context of user queries regardless of the wording or language used. This makes it possible, for example, to identify all cases of a specific adverse reaction across multiple data sources or accurately calculate the number of occurrences of particular safety events.

Benefits for Pharmacovigilance Teams

• Faster analysis of safety data and reports – automation of document processing and classification,
• Greater accuracy – hybrid semantic search and context-aware record counting,
• Integration with additional data sources – the ability to combine information from internal databases, CRM systems, and reporting platforms,
• Improved reporting to regulatory authorities – instant access to specific sections of documentation,
• Reduced analyst workload – less time spent searching through files and more time dedicated to risk assessment and result interpretation,
• Compliance with EMA and FDA requirements – full transparency and a complete audit trail of responses.

Examples of Recordya Applications in Pharmacovigilance

• automatic identification of AE and SAE cases across reports and databases,
• analysis of adverse event frequency in clinical reports,
• support for the preparation of PSUR, DSUR, and PBRER reports,
• screening of scientific literature for safety signals,
• combining data from clinical documentation and communications with regulatory authorities,
• integration with corporate databases and safety data management systems.

Document Types

• AE / SAE Reports (Adverse Events / Serious Adverse Events) – adverse event reports from clinical trials, doctors, patients, or partners,
• PSUR / DSUR / PBRER Reports – periodic drug safety reports,
• Case Narratives and Line Listings – detailed case descriptions and event listings,
• Clinical Documentation – study results, clinical trial data, CSR reports,
• Scientific Literature and Publications – articles, systematic reviews, and adverse event reports,
• Communication with Regulatory Authorities – EMA, FDA, URPL, MHRA, and others,
• Internal Procedures and SOPs (Standard Operating Procedures) – safety data management policies,
• Audit and Inspection Reports – results of internal and external PV audits,
• Email Documents and Partner Correspondence – e.g., reports from distribution partners or CROs.

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Why is it worth it?

In pharmacovigilance processes, every minute counts — and the number of documents being analyzed grows year after year.

Recordya provides fast and secure access to information that is critical for drug safety decisions.

Thanks to semantic and contextual search, integration with various data sources, and automated content analysis, the system significantly reduces the time required to process reports and helps avoid errors that may impact patient safety.

Recordya enables pharmacovigilance teams to manage drug safety knowledge quickly, consistently, and accurately.