Shanghai Xihua Clinical Services Co., Ltd. (Xihua Clinical), which is a wholly domestic subsidiary of Shanghai Xihua Scientific Co., Ltd. Xihua Clinical operates in both China and the United States, with offices in Shanghai, New Jersey . Xihua Clinical is committed to providing clinical data management, statistical analysis and programming services that meet international CDISC standards, as well as clinical pharmacology, quantitative pharmacology, and pre-marketing and post-marketing pharmacovigilance services.
Xihua Medical China team has undertaken more than 100 CDISC projects at home and abroad, and has assisted or represented clients to participate in FDA/EMA/CDE review meetings, communication program revisions, efficacy endpoint changes, statistical methods, etc., successfully supporting clients to pass FDA/CDE and other regulatory departments. Relying on the rich practical experience of domestic and foreign double declaration services and the perfect and mature quality management system, Xihua Medical will continue to provide domestic and foreign drug R&D enterprises with integrated professional digital services that meet the requirements of relevant laws, regulations and declaration requirements such as ICH/NMPA/FDA/EMA.
Adhering to the core service concept and commitment of "Quality & Punctuality", the Group is committed to providing global customers with clinical data management, statistical analysis and programming services that meet the international CDISC standards, as well as clinical pharmacology, quantitative pharmacology and pre market and post market pharmacovigilance related services.
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