The Challenges of Pharmacovigilance: Database and Reporting Solutions

In recent years, regulatory agencies - including the EMA/European Union and the FDA - have taken steps to improve patient safety in clinical trials. The EU estimates that approximately 200,000 patients die each year from Adverse Drug Reactions. Companies are often faced with the challenge of finding solutions that can improve quality and analysis of safety data while managing the increase in data and the need to satisfy regulatory requirements.

In Europe, the latest pharmacovigilance regulations, known as Good Pharmacovigilance Practice (GVP), went into effect in 2012 in order to better analyze and understand data from clinical studies, especially post-market studies, to identify risks to patients. More recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports.

 

Safety Database

 

Companies conducting pharmacovigilance activities will need a safety database that can optimize safety reporting. Many pharmaceutical and biotech companies may opt for Oracle AERS or Argus, while some store safety data in SAS. Oracle AERS is a comprehensive solution for product safety monitoring and compliance. The graphical user interface allows users to visualize the case elements and understand the holistic case picture. Oracle Argus, on the other hand, is a fully integrated platform of end-to-end pharmacovigilance solutions to ensure regulatory compliance from clinical development to post-market surveillance. 

 

Combining statistical analysis, programming and IT support under a commonly used platform like SAS is an ideal solution for automating data collection and analysis from multiple sources. This approach is even appropriate for smaller companies, because automation can be done without a complex or expensive Business Intelligence platform.

 

Customized Reporting Solutions

 

1. Automating signal detection in SAS is one ideal solution for customized reporting. In order to automate the process, a system needs to be in place to pull and analyze data from the safety database. The key aspect is the data integration between safety database, regulatory databases, and patient data from external database resources. The identification of signal criteria and the implementation of standardized programs automates the signal detection process and produces structured data which speeds up the task of finalizing Eudravigilance submissions.

 

2. Integrating an Oracle database with Business Intelligence produces real time data and results. With the support of our technology partner, we can integrate Oracle 9i database with Oracle Business Intelligence Standard One edition to create interactive dashboards for readily accessible data and results.