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Quality Assurance




    Our Services:

  • Set up and optimize clinical Quality Management System (cQMS), including development of professional regulatory compliant bilingual SOPs and quality manual
  • Investigator site audit for clinical studies of drug, medical device, diagnostic reagent and vaccine
  • Vendor qualifications audit and routine audit, e.g. PK lab, central lab, Bioimaging lab, pathology lab, New sequence generation lab, phase I unit, computerized system (CTMS, eTMF, IRT) etc.
  • GCP/GVP/GCLP system audit
  • Risk based process audit, e.g. TMF audit, informed consent process audit, protocol development audit, IDMC audit, safety letter distribution audit etc.
  • Self-assessment and Inspection readiness support in order to ensure the best inspection outcome via proactive and responsive support
  • Risk assessment, GCP significant issue investigation, risk & issue trending analysis as well as facilitating Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) development
  • GCP/GVP/GCLP expertise consultation, inspection readiness training

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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