MedDRA Version Management
Fluent in the Language of Safety Data
 The coding of medical terms has become a complex process. Some companies still use COSTART to code adverse events and need to move to MedDRA, a medical dictionary ten times the size of COSTART at the Preferred Term level alone. If your company has already transitioned to MedDRA, every upgrade to a newer version presents decisions and challenges regarding clinical trial and post-marketing safety data.
Sentrx can help you code or recode as you change medical dictionaries or safety systems. The health care professionals in our Safety Response Center possess clinical knowledge and familiarity with the structure and content of MedDRA, COSTART, WHOART, ICD9 and WHODrug; and our Information Technology staff has the expertise to develop the best strategy to recode and validate your legacy data.
If you're a hosted client, Sentrx manages MedDRA version upgrades for your company. Our IT and medical professionals upgrade the medical dictionary once or twice per year, depending on your reporting requirements, and recode adverse events, indications, medical history, diagnoses, datasheets and laboratory data. This provides our clients with a consistent dataset for signal detection and data mining activities.
After an analysis of changed Lower Level Terms (LLTs) , Preferred Terms (PTs) and System Organ Class (SOC) assignments against your synonym list, Sentrx utilizes EasyCode™, a unique and powerful auto-encoder. EasyCode™ automatically recodes the terms for which only the text has changed. Sentrx Medical Safety Officers review the distinct LLTs that no longer have a full hierarchy match in the new MedDRA version and choose the appropriate replacement. EasyCode™ then automatically recodes the cases containing these LLTs.
Sentrx also updates all datasheets and analyzes all pending periodic reports and period safety update reports (PSURs) for changes to MedWatch reports already submitted. Every MedDRA version upgrade is verified for accuracy and completeness, and thorough documentation of the project is provided to our clients.
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