IT and Computerized Systems:
Organic combination and integrated management of the rigorous logic-based validation life cycles of computerized systems with IT infrastructure maximize the security of electronic data for clients. Valuing data security above all else, the computerized systems and IT infrastructure have been systematically designed, validated, and managed with reference to the security concept of CISSP, which is regarded as the gold standard in the financial industry.
Instrument management system:
With more than 110 standard operating procedures (SOPs), an integrated instrument and equipment management system is available following the requirements of NMPA, OECD, FDA, MHRA and other national regulations.
A powerful standard verification system for pre-use items and routine and unconventional maintenance and calibration for the in-use ensure good performance of instruments and equipment throughout their life cycles, effectively securing the accuracy and reliability of the data generated, and providing solid supports for non-clinical studies..
File management system:
A sound partition management system has been established for paper, specimen and test product warehouses, with automatic monitoring, early warning and automatic adjustment of environmental indicators. An integrated system is also available for the electronic filing, access, online reading and online approval of documents.
Document management system:
Focusing on preclinical activities, the document service system consists of documentation, formatting, translation, statistics, tabulation, eCTD submission drafting, and SEND conversion. It provides services including but not limited to SOP maintenance and translation, standardization of various documents, bilingual drafting of study plans and reports in collaboration with the core departments, PV system maintenance, and eCTD forms filling, ensuring all-round, high-quality one-stop services to support multinational application.