Chris Reale

The GxP Group, LLC

Global Quality & Compliance Consulting Services Experienced GCP compliance consultants providing a wide range of GCP QA services, such as: Internal GCP QA resources supporting internal and external clinical teams with GCP direction and guidance -Implement study-specific quality plans -Partner with clinical management to conduct gap assessment or identify quality system improvements opportunities -CAPA support and management -Inspection readiness and support prior to, during and post inspection activities -Partner with IT/IS for electronic systems (eTMF, EDMS, Audit, CAPA) implementation External audits: -Clinical Investigator research sites, including inspection readiness and support -CROs, Vendors, clinical labs, bioanalytical labs, IRBs -Internal audits: -Clinical Processes/sytems (TMF, Clinical processes, DM, IMP) -Documents, eg. CSR, ISS, ISE, PV related, eg. PSMF -Quality Systems (Policy, SOP, WPs) review, development and management -Training for clinical research sites staff on regulatory Inspections and GCP / ICH