Areas of Expertise
Innovative and Cost Effective Technology Solutions for Life Sciences
MedDRA Terminology Dictionary Tools
Robust Tools for MedDRA/WHODRL coding and up-versioning of MedDRA Coded terms in Oracle Argus Safety™.
Over 30 years of experience implementing Product Safety and PV Systems for organizations of all sizes. Extensive knowledge of Oracle Argus Safety™ and Aris Global ARISg™/LifeSphere MultiVigilance™.
Computer System Validation
Modern and Flexible Systems Validation and Software/Systems Development Life Cycles for in-house and hosted/cloud systems that meet regulatory requirements.
GxP Systems Implementation and Compliance
Pharmacovigilance (PV) Systems, Adverse Event and Drug Coding Systems, Clinical Data Management/Electronic Data Capture Systems, Systems Implementation (Installation, Configuration, Validation, Data Migration).