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Ⅰ.Overview of Boji Data Management and Statistical Analysis Department
Boji Data Management and Statistical Analysis Department is fully responsible for its subsidiary, Bohuikang (Beijing) Data Technology Co., Ltd. Bohuikang has a data management team with a global vision with a rich experience in clinical research project operation. Bojican provide comprehensive data management and statistical services according to the client’s requirements through their DM (data management) department, statistics department and program department.
Employees of the DM department have extensive experience in the medical field, some having over 10 years of clinical data management experience. Whilecomplying with practices, regulations and systems such as GCP, industry technical guidelines and company SOPs, we apply standardized data quality management systems to ensure the security of relevant data and provide clients with high-quality and efficient data management services.
Committed to providing customers with comprehensive statistics services, the statistics team can customize clinical trial designs according to the characteristics of the trials and the interests of the sponsor at reasonable costs, good safety and a high probability of success. The team also provides analysis reports according to the latest standards at home and abroad.
The experienced SAS programming team has long been involved in and focused on the development of the CDISC standard at home and abroad. The programming team consists of a group of outstanding programmers with extensive experience in the industry, which mainly provides SAS programming support for clinical research projects.
Ⅱ.The organizational structure of Data Management Department and Statistics Department and the details of the staff in each department are as follows:
Ⅲ.Main business introduction:
(1) Data management services:
Data management for project management and risk control.
The plan of data management writing.
Paper CRF design and verification, Annotated CRF, CRF filling guide.
Data verification plan and logical inspection.
Database creation and testing.
Logic check programming and testing.
CRF entry guidelines development.
Data entry and comparison (paper project).
Case report formand data query form management (paper project).
CDISC standardization (CDASH / SDTM).
Fill out papercase report forms and train electronic data collection systems.
Electronic data acquisition system (EDC) support center.
Data verification and challenge management.
Medical coding (Dictionary of MedDRA, WHODD, etc.).
Severe adverse event consistency check.
External data management.
Local laboratory normal value management.
Database quality control.
Data extraction and transmission.
Data management’s report writing.
Maintenance and preservation of project related documents.
Third party audit.
Software for Boji's data management and statistical analysis department: Oracle Clinical,RDC, Apollo, Medidata, Datatrak.
(2) Statistical analysis services:
Clinical trial design.
Review research protocols and provide statistical support.
Sample size calculation and statistical evaluation of experimental design performance.
Randomized designand network randomization, providing statistical support for IRT system establishment and system management.
Formulat estatistical analysis plan.
Statistical analysis of data.
Create statistical analysis chart templates and review the output results.
Statistical analysis programming.
Generate analysis data set.
Generate tables, charts and lists (TFLs).
Trial and final analysis.
Write astatistical analysis report.
Assist in writing clinical research reports.
(3) Program services:
CDISC standard implementation, providing professional CDISC standardization services (generating SDTM / ADaMdata sets, Define.xml, SDRG and ADRG to support statistical analysis and submission).
SDTM data conversion.
ADaM data set creation.
Electronic data submits related documents (CRF notes, review guidelines and metadata definitionform).
Data management programming.
Statistical analysis programming.
Analysis data set creation.
Statistical chart making.
The data management and statistical analysis department has provided professional clinical research data management and statistical services to more than 200 companies, earning them deep trust and wide praise from our clients. They will continue to use the professional knowledge and experience as they serve more clients!