Automating Pharmaceutical Safety Surveillance process

Pharmaceutical companies invest huge amount of effort and cost in launching a drug into the market, keeping the two aspects in mind i.e. safety and efficacy. Post launching the drugs into the market, the organisations then need to monitor the adverse events from these drugs, and need to take the action accordingly. In this white paper few approaches are discussed for automating the post market safety surveillance processes in a cost effective manner. The pharmaceutical companies collect the adverse events data from various heterogeneous sources, and this collected data need to be analysed for the safety surveillance. Generally in post market safety surveillance processes, each Drug-Event case is processed record by record which is causing the exponentially rise of the records and finally leading to the high computational complexity and Analytics performances issues in the system. This paper will also focus on handling these Performances issues by bringing Hadoop environment into the Solution Implementation. The technical SAS solution to be discussed in this white paper will include components for Data Extraction and Transformation, Analysis, Reporting and Automated Processes for Signals detection & Investigation.