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The safety-reporting and pharmacovigilance niche is served by both specialty vendors and EDC companies. Homegrown applications created by and for sponsors are still a major factor.

Dealing With ...  Commercial Tools Can ...
"Heart attack," "myocardial infarction," "severe chest pain" Some programs can recognize MedDRA vocabulary and use thesaurus -like functionality to automatically match terms in reports from physicians to a pre-determined, approved company vocabulary.
MedWatch forms, individual case safety reports Some applications send the "spontaneous," "expedited," or "periodic" reports to the FDA on paper, CD-ROM, or electronically. In some cases, special EDI software from firms such as Cyclone or Templar must be installed. E2B format is key.
7 reports of myeloma in Peoria linked to a particular medication Software can extrapolate incidence, severity of a safety issue based on artificial intelligence algorithms, other mathematical tools. May also use databases to find drug- and prescription-related data nationally or globally.
"My pills were wet, not dry, and now I'm feeling blue."  If a patient has both a product-related report — mold on the medication — and an illness-related report, some tools can split the incident into two, tracking the manufacturing and clinical issues separately.
My report is due when? Are we selling this in Bulgaria?  With overlapping international jurisdictions, and multiple formulations of the same drug, it can be tricky to know which data must be sent to which authorities in which countries. Some vendors support Japanese characters.
Integration with EDC, CDMS, CTMS, other systems All safety vendors can work with paper or electronic data but prefer electronic. Reconciliation with the original electronic data for the case is necessary. Some EDC vendors connect with safety systems.
SOURCE: BIO·IT WORLD

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