中文

Drug Safety & Pharmacovigilance




      Our Services:

      Clinical Trial Drug Safety Service:

    • SAE report receipt and processing, including MedDRA coding and narrative generation
    • Safety medical review for SAEs
    • Expedited SAE/SUSAR reporting
    • Notification to investigators
    • Development Safety Update Report preparation
    • Risk control plan for China IND application

    • Post-Marketing Safety Surveillance Service:

    • AE report receipt and processing, including MedDRA coding and narrative generation
    • Safety medical review for AEs
    • Expedited ADR reporting
    • Periodic Safety Update Report and Annual Safety Summary Report preparation
    • Risk management planning for China NDA
    • Chinese literature search and review

    • Safety Database:

    • Argus bilingual platform (English and Chinese simultaneously)
    • Compliance with FDA 21 CFR Part 11
    • Generation and submission of ICSRs in Chinese using ICH E2B (R3) format, in addition to other global standard formats
    • Pharmacovigilance Consulting Services:

    • Preparation of standard operating procedures and working instructions related to pharmacovigilance activities
    • Assist in preparation of safety data exchange agreements
    • Pharmacovigilance training
    • Drug safety and pharmacovigilance project oversight

China:
298 Xiangke Road, 3/F, 301-305, Zhangjiang Hi-Tech Park, Pudong, Shanghai 201210, China
Tel: +86 21 5090 0085 Fax: +86 21 6875 5515
US:
261 Madison Avenue, 24th fl. New York, NY 10016 US
Phone: +1-212-681-2100
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