Bio-pharmaceutical companies are continually tasked with gathering more safety information and responding to requirements more quickly.
These new requirements have significant implications for pharmaceutical companies, as health authorities look to reduce treatment-related health risks to patients, pharmacovigilance (PV) or drug safety has stepped into the spotlight.
Applied Clinical Trials Online recently featured a commentary authored by James Pierce, Appian's Global Pharmaceutical Practice Leader, discussing how enterprise application platforms may provide the solution to enable PVteams to do away with problems in regulatory compliance and reporting ñ and reduce risks to patients using approved medical products. In the piece, James examines areas of process automation within a modern application thatcan improve PV effectiveness including faster signal adjudication and reporting, task management, increased activity visibility, and standardized processes with local variations.
Appian's enterprise application modernizes drug safety monitoring by automating all aspects of adverse event case management and eliminating inefficient manual processing. Appian improves execution of Safety Information Management processes by reducing time from signal detection to adjudication and labeling changes, streamlining data collection methods in accordance with global regulations, and reducing costs for managing safety information systems globally. Using Appian creates optimized compliance capabilities while allowing for effective risk management and minimization of potential future litigation costs.
Be sure to read the rest of James' commentary to gain insights into the most modernized and effective approach to pharmaceutical compliance monitoring.
-Mike Ingrisano, Media Relations Manager
