Complete compliance, multi-dimensional presentation, data format based on international standard CDISC and data flow based on NMPA data guidelines as the principle. Collect and study relevant documents from the initial finalization of the scheme, start-up data setting (CRF design, database preparation, etc.), database locking and data closing at the end, and delivery of fixed format data sets and data supporting documents.
Data management and process setting based on the clinical research center and the customized data tools make data processing and feedback faster, then enables the dose group adjustment more flexible.
EDC system design, built and test
DMP, DVP, QC plan, CRF filling guide and a series of project documents writing
Data cleaning - system verification & manual verification
External data management
SAE consistency verification
Data blind audit conference
Database locking and dataset delivery
Data management report writing
Follow up CDISC standard and connect domestic and international seamlessly
1、Implemented the international leading CDISC standards: Double back-to-back programming, meticulous and strict process for design in order to achieve the requirements of statistical analysis plan. This specification smoothly meets the submission requirements of each regulatory agencies, and to transform and connect with each other.
2、Adopt innovative tools to speed up the clinical trial:
a) Bayesian Analysis method was applied to improve the accuracy and efficiency of research and development by using i3+3, mTPI-2, R-TPI and other experimental design methods in phase Ia dose climbing; improve safety; and apply scrolling into the group to shorten the test duration about 10%-25%;
b) In phase Ib cohort to expand trial test, multiple doses and multiple indications were used to expand at the same time, which saved the test sample quantity; improved the flexibility; saved the development time;
c) Main protocol and seamless design: study multiple therapeutic drugs or/multiple diseases in one protocol at the same time; adopt umbrella/basket/platform design to carry out multiple groups or common control groups, and screen multiple biomarkers at the same time; to fully utilize data in each phase to improve statistical efficiency and shorten development time.
Clinical protocol design
Develop SAP and TFL templates
TFL generation and audit