Clinical trials and pharmacovigilance activities require the coding of diseases, labs, events and products using the standard dictionary terminologies including MedDRA and WHO-DDE (WHO Drug Dictionary Enhanced).
Coding inconsistencies during case processing can result in significant recoding effort during periodic report preparation and also hamper the analysis of the data. With updates issues bi-annually, the MedDRA upgrade process is often cumbersome, resource intensive and disruptive. It is important to efficiently handle the upgrade process and determine the impact of any upgrade on the legacy data.
In order to ensure consistency of coding many companies have implemented a central coding group with the sole responsibility of ensuring that all medical terms are coded quickly, consistently and accurately.
LifeSphere Central Coding™
LifeSphere Central Coding is a central coding solution that seamlessly integrates with LifeSphere Safety Database, other safety case handling systems including Oracle Argus™, and other third-party tools such as clinical data management/EDC systems. With standard APIs and webservices, it receives verbatim (reported) terms from any compatible source system and performs auto-coding against the specified dictionary using advanced coding algorithms and defined synonyms, returning the coded terms back to the source. LifeSphere Central Coding supports adverse event term dictionaries (MedDRA) and product dictionaries (WHO DDE, Japanese Drug Dictionary) facilitating the management of each dictionary including upgrade/impact analysis and recoding.
LifeSphere Central Coding allows coding specialists to resolve multiple records at once that use the same term, perform advanced searching, and manually code newly encountered verbatim terms either as one-offs, or with a permanent verbatim term assignment to a preferred term. LifeSphere Central Coding provides a coding inbox for each coding specialist that allows for grouping and prioritization based on date, seriousness, etc. It offers a configurable workflow of one or more steps that allows for both coding and review of terms. In the case of WHO DD, an optional supplementary workflow step allows assignment of ATC codes, based on the indications of the product in question.