Consulting

  • Study Design
  • Statistical Modeling to test design assumptions
  • CDISC & Legacy Data Mapping, FDA Data Warehouses (JANUS, AIMS)
  • Laboratory Data Standardization (LOINC, HL7)
  • GCP / GMP training and auditing
  • Coding (MedDRA, WHO Drug) training - remote and onsite
  • Ad-Hoc Medical Coding / standardization
  • DSMB Support Services
  • SOP Gap Analysis, SOP Development and Training
  • Vendor Qualification / Process Assessment & Auditing
 
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