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