A new version of software designed to reduce the time and cost of coding clinical data terms to industry-standard dictionaries has been launched by Phase Forward, the US specialist in integrated data management for clinical trials and drug safety tracking.

Central Coding for InForm 2.0 is an update of an application originally launched in March 2006. The Web-based solution is optimised to code clinical data within Phase Forward’s InForm Integrated Trial Management electronic data capture (EDC) product.

As Phase Forward points out, most companies conducting clinical trials have to match the variety of study data terms captured to a set of common terms in industry-standard dictionaries, such as the World Health Organization’s Drug Dictionary and the Medical Dictionary for Regulatory Affairs, for adverse events and medical coding. Trial sponsors continue to invest “heavily” in clinical process redesign, staffing and system applications to support the dictionary coding management process, with the aim of improving consistency, providing better cross-trial analytics and simplifying preparation for regulatory submission, it notes.

“Our customers tell us that ensuring adherence to dynamic clinical term dictionaries presents a formidable challenge,” said Phase Forward senior vice-president Steve Rosenberg. According to the company, the coding process offered in many EDC systems can be time-consuming because simplistic algorithms force coders to square the majority of their study data with standard terms manually. Moreover, the frequency of dictionary updates “makes it extremely difficult for companies to recode their clinical data to the latest standards once the coding process has been initiated using older dictionaries”.

In response to these needs, Central Coding for InForm 2.0 now provides tools to reduce the manual coding required to keep pace with standards in multiple dictionaries, as well as an advanced, centralised multi-trial coding environment that streamlines the initial coding process. Other new features include the ability to compare differences between any industry-standard dictionary version, and to review and reconcile previously coded verbatims based on dictionary differences and algorithm matching.

As the coding process becomes a more strategic element of new customer trials, there are currently more than 40 Central Coding for InForm studies in live production, Phase Forward says.