Mary joined Nuventra in 2011 and has more than 25 years of experience in DMPK, nonclinical and clinical PK data analysis/interpretation, as well as QC/QA in both big pharma and CRO companies. At Nuventra, her main focuses are non-clinical (GLP and non-GLP) TK analyses and Phase 1–3 clinical analyses using NCA methods to support client needs over a wide range of therapeutic areas. Mary is also experienced in protocol writing/review and sample collection time determination/review. She is also knowledgeable in CDISC STDM, ADaM, and SEND for PK related domains as well as submission ready format (eCTD). Also, as a former QA manager, Mary has extensive knowledge of GLP, GCP, and Part 11 regulations, SOP writing, as well as regulations applicable to PK related processes and validation.