Cliniserve, India

Established in Feb, 2011 to support monitoring and auditing service in Clinical Research- We provide support in Bioequivalence studies, Phase I, Phase II and Phase Clinical Trials at more than 250 investigator sites and more than 25 CROs across the globe- Monitored studies for different sponsors from US, EU, China, Brazil, Malaysia, Chile, Taiwan and middle east countries at Indian CRO- Performed various monitoring activities including: Site Selection Visit, Site Initiation Visit, Interim Monitoring Visits, Bioanalytical Visits and Site Close-Out Visit- Monitored over 1200 Bioequivalence studies across the globe including 06 first to file ANDA submission studies- Experience in performing following audits: System Audit, Gap Analysis, Study Specific Audit, Issue-based Audit, GCP Audit, GLP Audit and GMP Audit activities- Have audited various CROs, Pharmaceutical industries and Laboratories across India, Canada, Spain, Jordan, China, Poland, Netherlands, etc- GCP trained Clinical Research Professionals and familiar with applicable Regulatory Authorities, ICH GCP, USFDA, Health Canada, EMA, CDSCO, ANVISA guidelines.