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Clinical Operations




      Our Services:

      Integrated approach for Phase I-IV study project management and execution in various therapeutic areas

    • Provide overall study management and execution, including but not limited to feasibility study, site selection, study start-up, subject enrollment and retention, site monitoring, site close-out within the study timeframe and budget.
    • Ensure high quality and compliance with ICH GCP, local regulatory requirement and the relevant standards in project execution
    • Embed Risk-Based Monitoring concept such as centralized monitoring, specific risk management based on trial design and study phase, to increase the effectiveness of on-site monitoring

    • Trial oversight and inspection readiness

    • Provide independent (third-party) oversight service to entire trial execution or specific activities, e.g. site self-assessment and/or inspection readiness
    • Set-up a reporting mechanism for significant and critical quality issues and ensure the necessary escalation and effective CAPA

    • Value-added service

    • Clinical Operations quality system and SOPs development
    • CRA and Study Manager training programs

China:
298 Xiangke Road, 3/F, 301-305, Pudong New District, Shanghai 201210
Tel: +86 21 5090 0085 Fax: +86 21 6875 5515

United States:
3800 Paramount Pkwy, Suite 100 Morrisville, NC 27560
Tel: +1 919-224-8800

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