Phase Forward Introduces Time-Saving Functionality to Solve Industry Challenge for Recoding Clinical Data
WALTHAM, Mass.–(BUSINESS WIRE)–Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced Central Coding™ for InForm™ 2.0, a new release of a Web-based application optimized to code clinical data within Phase Forward’s InForm Integrated Trial Management (ITM) electronic data capture (EDC) product to industry standard dictionaries.
Most companies conducting clinical trials must map the variety of study data terms they have captured to a set of common terms contained within industry standard dictionaries, such as the World Health Organizations Drug Dictionary (WHO-DD) and the Medical Dictionary for Regulatory Affairs (MedDRA), for adverse events and medical coding. Sponsors continue to invest heavily in clinical process re-design, staffing and system applications to support the dictionary coding management process with the goals of improving consistency, providing better cross-trial analytics and simplifying the submission preparation process. The time and cost to code clinical terms are strongly dependent on the clinical knowledge of the coder, the management of dictionary and synonym versions and the coding algorithms used to automatically code clinical events.
The “coding process” offered in many EDC systems can be time-consuming because simplistic coding algorithms force coders to manually match the majority of their study data to standard terms. In addition, the regularity of newer dictionary versions 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.
The Central Coding for InForm 2.0 application gives companies the tools to address these important challenges. In addition to providing an advanced, centralized multi-trial coding environment that streamlines the initial coding process, Central Coding for InForm 2.0 now offers tools to reduce the manual coding required to recode clinical data to reflect the latest standards in multiple dictionaries.
New features in the Central Coding for InForm 2.0 application offer users the ability to:
- Compare the differences between any industry standard dictionary version
- Assess the impact a new standard dictionary will have on an existing study
- Review and reconcile previously coded verbatims based on dictionary differences and algorithm matching
- Review and reconcile synonym lists based on dictionary differences
In addition, the Central Coding for InForm 2.0 application now supports Oracle Database 10g.
“Our customers tell us that ensuring adherence to dynamic clinical term dictionaries presents a formidable challenge,” said Phase Forward Senior Vice President Steve Rosenberg. “We have developed Central Coding for InForm 2.0 in direct response to this input. The tools and functionality provided in Central Coding for InForm 2.0 are designed to help our customers reduce the time required to meet this challenge.”
Launched in March 2006, the Central Coding for InForm application has been enthusiastically adopted by Phase Forward customers. As the coding process becomes a more strategic part of new customer trials, the functionality offered by Central Coding for InForm takes on more importance. Indicative of this trend, there are currently over 40 Central Coding for InForm trials in live production.
The Central Coding for InForm application is available now as either an Application Service Provider (ASP) or Enterprise Adoption (EA) solution for Phase Forward InForm users.
About Phase Forward
Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. The company offers proven solutions for electronic data capture (InForm™), phase I clinic automation (LabPas™), clinical data management (Clintrial™), clinical trials signal detection (CTSD™), strategic pharmacovigilance (WebVDME™ and Signal Management), adverse event reporting (Clintrace™) and applied data standards (WebSDM™). In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 250 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, GlaxoSmithKline, Harvard Clinical Research Institute, Merck Serono, Novartis, Novo Nordisk, PAREXEL International, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Servier, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency. Additional information about Phase Forward is available at www.phaseforward.com.
