As an Independent Consultant, Alia conducts domestic and international routine, directed (for-cause), qualification, re-qualification, and inspection readiness audits, as well as mock inspections of investigator sites, CROs, Sponsors, vendors, compounding pharmacies, drug manufacturers, packagers, or labelers to assess compliance with applicable regulations, protocols, investigational plans, Standards Operating Procedures (“SOPs”), International Conference on Harmonization (“ICH”) Good Clinical Practice (“GCP”), Good Manufacturing Practice (“GMP”), Good Laboratory Practice (“GLP”), Good Clinical Laboratory Practice (“GcLP”), and Good Pharmacovigilance Practice (“GVP”).

Alia also provides training and training materials to compounding pharmacies, Sponsors, CROs, vendors, and investigator site personnel on topics such as inspection readiness, FD&C Act, 21 CFR, Compounding Quality Act, ICH GCP Guidelines, Human Research Subjects, Institutional Review Boards (”IRBs”), inspections and audits, regulatory guidance documents, and current topics in compounding pharmacy and clinical research.

Expert consultant conducting audits of domestic and international investigator sites, CROs, Sponsors, and vendors to assess compliance with protocol, SOPs, ICH GCP, GcLP, and all applicable regulations; preparing written preliminary summaries and audit reports regarding audit observations; and ensuring the timely and effective follow up of all identified or assigned quality issues, and reviewing TMFs, including a variety of regulatory documents (e.g. FDA 1572s, informed consents, financial disclosures) for accuracy and completion.

Senior Auditor conducting audits of data management, biostatistics, and programming vendors to assess compliance with the protocol, 21 CFR part 11, ICH GCP, good programming standards, study-specific plans, Software Development Life Cycle (SDLC) principles, business continuity/disaster recovery plans, global data privacy/data protection policies, company SOPs, and current industry concepts in computerized system validation.

Quality Assurance Consultant/Senior Auditor conducting audits of domestic and international investigator sites, CROs, Sponsors, and vendors to assess compliance with the protocol, SOPs, ICH GCP, GMP, GLP, GcLP, and all applicable regulations; providing input into QC plans and processes relating to assay validation and environmental monitoring; reviewed SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations;