Coding tools

The FDA has adopted the MedDRA dictionary for coding the adverse event data stored in the FDA adverse events reporting system database and Manufactures are encouraged to comply with the FDA requirements. In the next years, all expedited (serious) adverse drug reaction reports will be submitted electronically to major global regulatory agencies (

FDA, EMEA, MHW), using MedDRA terminology. MedDRA is the language of communication among pharmaceutical manufactures, regulators and CROs. Therefore, new tools and skills are required. It is strongly recommended to implement a coding tool which answers the internal coding and dictionaries related needs. The coding tool should provide functionalities enabled to:


• Manage MedDRA dictionary updates and all other dictionaries.
• Browse the MedDRA content.
• Code data with the latest updated version of MedDRA dictionary using same synonyms, same stopwords and same algorithm
• Quantify the impact analysis on data before implementing a new version of dictionary
• Edit listings and help improving the synonym table if available
• Provide large capabilities of search at all levels of the dictionary (beginning, containing, ending, and, or, searching for two keywords …)
• Provide patients and sites information
• Audit History

Listed below is a selection of various coding tools available in the market:

• ID-code
• DS Navigator
• Medicoder
• Lingway
• PPD
• BKP

 

For more information about Pharmadhoc and its services, please feel free to contact M. Azzouzi at +33 (0)8 71 76 88 17,
or send an email to Pharmadhoc