Prakruti Trivedi's Colleagues at Cliniserve, India
Prakruti Trivedi's Contact Details
Ahmedabad,Gujarat,India
Cliniserve, India
Prakruti Trivedi's Company Details
- 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 III 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.