Validating Adverse Events On A Large Scale
Adverse Events coded by IDDI Medical Coding System
Two pivotal trials were conducted (one in the US, one in Europe) to seek approval of a new treatment for a chronic condition in elderly patients. The safety of the new drug was of particular concern. Adverse events and medications were coded by IDDI using proprietary coding system ID-code, based on the standard MedDRA and WHO-drug dictionaries. More importantly, the large volume of over 36,000 coded terms could easily be validated by the Sponsor using real-time, web-based technology. This cut the time required by several months, and the budget by almost half a million dollars.