MCJ Drug Safety Consulting, LLC
"Accurate Information for Reliable Medical Decisions"
High Quality and Cost-effective MedDRA Management

The MedDRA WorkbenchSM is an integrated suite of web-based utilities which provides comprehensive MedDRA dictionary management. The application implements advanced concept-based (medical meaning) algorithms to support accurate coding, consistency review, and versioning in MedDRA 4.0 and later versions.

General capabilities include a user-friendly intuitive interface, multiple user privileges, maintenance of client synonym tables, an integrated browser, and file formats compatible with industry standard systems.

The MedDRA WorkbenchSM is a collaboration between MCJ Drug Safety and IVC, Inc. since 2004.

IVC, Inc. is in the business of providing customer facing solutions that support a broad range of interactions between businesses and customers.

Medical Informatics Strategies:

Version specific workspace by client, project, or study

Upload your synonym table or verbatim file to a secure company area

Efficient coding procedures

Approved client coding assignments are accessible 24/7 by geographically distributed coders working on complete or partitioned verbatim files

Interactive coding enhancements
Focused “Smart Hints” are based on client specific coding history to assign uncoded terms, decreasing “coding drift” from browsing and searching MedDRA

Monitored coding assignments
Multiple levels of authority include approval to add new coding assignments to the synonym table or reject incorrect codes

Detailed status reports and transaction history
Review audit trails by user, file, record, task, and action
Verbatim edit checks identify uncodable terms to shorten query timelines
Version-specific review of MedDRA codes in coded files and synonym tables reveal invalid assignments

Version Management
Analyze changes in the full MedDRA dictionary or a coded file
Accurate recoding for up-versioning, pooling, or comparisons

21 CFR Part 11 Compliant



MCJ Drug Safety Consulting, LLC
(919) 923.3907
FAX (919) 644.1075

info@mcjdrugsafety.com


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