Enhancing the use of MedDRA in an intelligent online adverse event reporting portal

The process of drug development requires close monitoring of medical events experienced by patients both during clinical trials and post-marketing. Without this critical safeguard, patient safety is put at risk, as well as jeopardizing companyreputation, loss of revenue and fall in share price if a product is subsequently withdrawn. Such diligent monitoring relies upon comprehensive reporting together with accurate statistical evaluation.

MedDRA expert Jane Knight explores the changing world of Pharmacovigilance through advances in technology in this white paper, and highlights the benefits of terminology and technology working in alignment to revolutionise the future of safety data capture. “Key objectives remain identical as they develop and evolve; to maximise transparency, resource-efficiency, speed, accuracy and consistency in submissions to regulatory authorities through real-time risk management systems”.