Naukricare

Our clinical monitoring and site management services include:

• Site identification and feasibility
• Review of inclusion exclusion criteria and the proper consenting of all subjects
• Site selection and qualification visits
• Assist with obtaining approval from local Ethics Committees and Institutional Review Boards
• Managing subject recruitment
• Review of quality systems at the site and ensuring all sites are audit ready
• Initiation, interim monitoring, and study closure visits
• Essential document collection, review and processing
• Good Clinical Practice monitoring, including motivational and training visits
• CAPA plan development and implementation
• Source documentation review, CRF review and query resolution
• Accountability for all study documents and materials
• Communication with sites
• Study specific training to site personnel
• Review of Investigational Product accountability and storage
• Review of safety information of all subjects
• Logging and correcting protocol deviations
• Monitoring study progress
• Database lock and study close out
• Mass mailings and newsletters to sites

• CARDIOVASCULAR
• METABOLIC
• NEUROSCIENCE
  • • NEUROSCIENCE
    • Alzheimer’s Disease & Dementia
    • Neurology
    • Pain & Addiction
    • Psychiatry
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• ONCOLOGY
• RARE DISEASE

( DCGI, USFDA, UK-MHRA, Chile, ANVISA, TGA and WHO Approved Clinical Research Site )

• Independent Monitoring-GCP, GLP, GMP
• CRO, Principal Investigator Selection
• Outsourcing Bioequivalence and Clinical studies
• Study Reports and Data review- retrospective Audit
• System Audit of CRO, CMO, Plants,
• Business Development for CRO, CMO