ClinicalAuditing.com™
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ClinicalAuditing.com™ Details
ClinicalAuditing.com™ provides international Clinical Quality Assurance Auditing, Clinical Quality Management, and consulting services to the Pharmaceutical, Biotech and Medical Device industries in the area of Good Clinical Practice (GCP).ClinicalAuditing.com™, LLC brings a wealth of knowledge to any companies seeking to improve quality systems and processes within their organization by offering the following independent QA support and services worldwide:GCP audits • Investigator sites • Service Providers • Ethics Committees • Trial Master File • Regulatory Inspections GCP process audits • Study Management • Clinical Monitoring • Drug Safety • Clinical SuppliesQuality Management System (QMS) • QMS gap analysis • Root cause analysis • Implementation of QA plans • Corrective & Preventive Action (CAPA) management • Due DiligenceTraining and development of Good Clinical Practice (GCP) programs • In house GCP training of sponsor or CRO clinical staff • Investigator site staff conducting clinical studies
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