中文

Increase the probability of your
products' success
dMed + Clinipace
Together as One

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, 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

沪ICP备16041651号-1 Copyright © 2016-2022 dMed All Rights Reserved
沪公网安备 31011502005403号