Drug safety and risk management

Pharmacovigilance and Safety 

Pharmacovigilance (PV) involves the receipt, triage, data entry, coding, medical assessment, distribution, aggregate reporting and archival of AE data and supporting documentation.  Historically, due to regulatory focus on expedited reporting of individual case summary reports (ICSRs) most pharmacovigilance (PV) departments have focused on the time consuming process of case management, with two leading case processing systems emerging in Oracle ArgusTM and ARISgTM.

More recently, regulatory agencies have focused their priority on the areas of signal detection and risk management.  This shift in focus mandates proactive and reactive analysis of a product’s risk benefit profile, beyond ICSR processing alone.   In essence, case processing has gone from being the ultimate goal of a pharmacovigilance department, to the lowest level of compliance required among many other activities around the detection, assessment and understanding of safety signals for medicinal products in all stages of the developmental product life cycle. 

Concurrent to increased regulatory demands, greater patient awareness means the industry as a whole is experiencing a significant increase in the volume of adverse event reports.  This increase will only continue to grow with the rise of patient support programs, social media, and other consumer inputs.  Due to the global nature of the pharmaceutical industry, license agreements between companies, as well as outsourcing portions of case processing activities to vendors also increases the complexity of the pharmacovigilance business model. 

As such, PV groups are searching for IT solutions that can streamline case processing, in order to allow their staff to focus on the higher level functions of signal detection and analysis.  The traditional processes are no longer sufficient and companies are looking for solutions to bring significant improvements in efficiency while complying with international regulations and guidelines.

The key functions of PV can be defined as:

  • Case receipt (regardless of source or medium)
  • Triage Case processing Literature search and adjudication for adverse events
  • Medical coding
  • Medical assessment
  • ICSR reporting to partners and authorities
  • Investigator notification Ethics committees/IRB notification of safety cases
  • Aggregate/periodic reporting
  • Signal detection Risk management
  • Metrics and analysis
  • License agreements/pharmacovigilance exchange agreements

There are many aspects to PV and this has resulted in plethora of niche systems to complement the core case management systems. But there has been no single, broad approach to PV, until now.

LPV is designed to work with your legacy case processing system. Almost all components of the LPV platform can be run as individual applications that can be seamlessly integrated with any case processing system including Oracle Argus.

Further, as technology continues to drive our day to day lives, the new disruptive technology is clearly the internet and the smartphone, with the myriad of Apps that transform our personal and work life. ArisGlobal is a pioneer in Pharmacovigilance. We offer innovative solutions and disruptive technology to transcend all traditional PV processes.