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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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