Future optimization of coding
processes and technologies
European MedDRA User Group Meeting
Glasgow
28 March 2017
Future trends affecting coding
functions
• Increase in case load in the post-marketing area (social media,
patient organizations, unauthorized product use, etc.)
• New Regulatory guidance like e.g. EMA IDMP initiative and
Indication coding guidance
• More specific Regulatory requirements (vague terms)
Compensate increased workload by increase in coding
staff? But: Well qualified Coders are hard to find and how
to keep coding consistency?
„Coding“ by Investigators?
Outsourcing of coding tasks to CROs?
Process and tool optimization to be considered in addition
Future optimization of coding
processes and technologies (1)
• Coding organization
– Centralized versus decentralized approaches
– Centralized processes require technical interfaces to databases
of main customers
• Established solutions for automation of coding processes
– Auto-coding
– Synonym lists (Only one? Separate lists for AEs, medical history
etc.?)
– Patient based versus term based coding
– Code lists
Future optimization of coding
processes and technologies (2)
• New approaches
– Patient self-reporting
• Via mobile devices in clinical studies
• Via web portals in post-marketing
– Automatic text recognition, streamlining reported terms
– Artificial intelligence (IBM Watson) implemented in coding
process
• Panel discussion
– Your questions?
– Other innovative approaches?
– Related experiences/ plans?