Cliniserve, India
Hospital & Health Care - , Gujarat, India
Cliniserve, India Employees
Cliniserve, India Senior Management
Cliniserve, India 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.
Cliniserve, India Technologies
Frameworks and Programming Languages
ASP.NET
Email Providers
Outlook
Load Balancers
Microsoft-IIS
CMS
WordPress.org
Hosting
GoDaddy Hosting
Other
Mobile Friendly