Indivirtus – CRO Offers Real Time Cost Effective Solutions.

  • 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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