Data Management
The members of the team have a deep background related to the pharmaceutical field and rich experience in clinical data management, and have undergone specialized training in clinical data management. The data management team can utilize various other clinical data management systems according to clients' needs. We are able to provide high quality and efficient data management services to our clients and strictly follow the relevant laws, regulations and guidelines.
Specific operations include:
Data Management Consulting
Data Quality Control and Assurance
Database Design and Creation
Data Management and Management Progress Reporting
Data Management Training
Blind Data Audit Session Conducted
Data Cleaning
Database lock and handover
Consistency comparison of external data such as SAEs
Document archiving and preservation
Medical coding (dictionaries such as MedDRA, WHO-DD, etc.)
Statistical Analysis
The statistical team has senior industry background and rich business experience, and can design more efficient, more successful probability, and more in line with the regulatory requirements of the clinical research program from the statistical point of view, which greatly improves the quality and efficiency of the follow-up statistical analysis work, and provides reliable data protection for clinical research, so as to make the clinical research more valuable and meaningful.
Specific services include.
Provide professional statistical consulting services for clinical research
Programming to generate statistical reports
Program statistical design according to statistical principles and regulatory guidelines requirements
Preparation of statistical analysis reports
Write and review protocols for statistical analysis and sample size estimation.
Assist in writing and reviewing clinical study reports
Responsible for generating randomization and contingency letters, participating in the design of IWRS, generating randomization tables, and directing drug blinding.
Interim analysis and Data Monitoring Committee (DMC) data analysis.
Review of CRFs, review of Data Management Plans and Data Verification Plans.
CDISC standards implementation
Compile statistical analysis plans and statistical report templates
Produce clinical trial submission datasets
Compile and refine analytical dataset specifications and program analytical datasets according to analytical dataset specifications.
Assist in the completion of the National Board verification site data reproduction