Alexis Baitelman

Consulting and support of pharmaceutical companies and contract research organizations on the design and implementation of RTSM systems. - Clinical supply chain management - Trial medication demand planning and monitoring - Operational clinical logistics management - IVRS/IRT requirement specification - IVRS/IRT user acceptance testing design and management - IVRS/IRT change mangement - IVRS/IRT operational issues management - IVRS/IRT software validation

• Experience with EDC systems (ClinBase, InForm, DataLabs), Identification and report of Protocol Violations • Data Cleaning and Query Generation, application of Self-Evident Corrections, Manual Listing Checks for Query Review • Early and Final Database QC Activities, SAE reconciliation, Database Soft & Hard Lock • Review of study protocol/CRF and creation of DVS, User Acceptance Testing, Alpha Testing, CDISC / SDTM Fundamentals Training • Compliance with applicable ICH-GCP Guidelines

Clinical, Hospital, and Managed Care Pharmacy - Conducting clinical trials (Monitoring) - Regulatory Affairs - Clinical trial logistics - Clinical data management - Electronic data capture, validation and medical coding

Animal Physiology Sensory and Behavioural Biology Biological Psychology Neurobiology