Central Coding

Sponsors and CROs of all sizes are conducting a greater number of complex, global clinical trials, and, as a result, investigator sites are expanding into new locations and performing multiple trials simultaneously. This evolution in drug development has highlighted the challenge of coding medical terms across studies, regions and languages. Phase Forward's Central Coding application can help alleviate these complications and provide greater efficiencies to the coding process through automation.


Central Coding is a customizable, multilingual, Web-based coding and dictionary management application designed to automate the coding process and minimize the manual effort required to code verbatim terms. Optimized to work with the InForm Global Trial Management (GTM) solution, Phase Forward's industry-leading electronic data capture (EDC) product, and the Clinitrial data management system, the Central Coding module streamlines the coding process, increases coding consistency and potentially drives down costs by allowing cross trial coding and effectively managing multiple dictionaries and dictionary versions. Sponsors and CROs now have a centralized means to code, review, resolve and approve terms—all of which can happen simultaneously across staff, sites, trials and locations.

 

During the course of many clinical studies, it is sometimes necessary to change the version of the dictionary that the study is coded against. When a new version of a dictionary becomes available, the study sponsor may choose to use the new version, and in some cases it may be mandated by regulators.  Medical teams can use impact analysis features to view dictionary changes, evaluate the impact on study data and reconcile any differences to existing terms, codes and synonyms.

Efficiently Code Medical Terms Across Trials in a Single Environment

       

  • Code verbatims entered in any language across multiple trials
  • Search and sort across all character sets, including Japanese and Chinese
  • Review, resolve and approve coded terms simultaneously, across staff, sites, trials and locations
  • Support multi-lingual and multi-level dictionaries in English and Japanese, including WHO-Drug Dictionary (WHO-DD), the Medical Dictionary for Regulatory Affairs (MedDRA and MedDRA-J) and J-Drug
  • Configure to support hierarchically structured custom or proprietary dictionary formats

Reduce Manual Coding Efforts

        

  • Improve auto-code hit rate by leveraging robust algorithms, synonym lists, and propagation functions
  • Use auto-suggest to recommend a past coding choice for a new verbatim
  • Reduce manual coding efforts using autocode, approve and populate functions
  • Increase the speed and accuracy of auto-coding using definable stop-word lists
  • Interface directly to the InForm environment for eCRF reference and query initiation

Effectively Manage Multiple Dictionary Versions

        

  • Easily manage multiple dictionaries and multiple dictionary versions
  • Update coded terms within a trial to a newer dictionary using impact analysis and reconciliation tools
  • Complete audit history provides a date and time stamp for all changes
  • Ready-to-run reports for coding classification, consistency, coded items and user reports