Data Entry is performed with accuracy, completeness, legibility, and timeliness of the AE information extracting maximum details from the source documents into the PV database.
End-to-End Data Entry & Case Assessment (DECA) is done considering below steps –
MedDRA Coding of Events :MedDRA coding of the event term is performed either auto code or manual.
Drug Coding: Coding of given suspect/concomitant/interacting done in the Drug Dictionaries. Non-Company Drugs are coded as per the WHO Drug Dictionary (WHO DD).
Causality Assessment:Reporter’s causality assessment is performed automated along with the manual case causality
Expectedness Check:Expectedness / Listedness is performed both ways; automated as well as manual referring the RSI
Case narrative:Case narrative is auto-populated within a predefined template for writing narratives as per the customer requirements. Summary of the events completeness, chronology, and sufficient detail in a narrative is fully ensured till case outcome.
Self-QC: The validator provided in the database facilitates Self-QC for the entire case before the case is pushed to the next workflow. This ensures the completeness and accuracy of the information entered into the database for all the cases.
FUP Information: Drafting of queries for the missing information are sent to the reporter via mail, fax, or phone, and once the reply is received, the data is updated in the case.
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