With decades of experience and extensive industry knowledge, WuXi Clinical provides accurate and integrated clinical data while adapting to customer trial’s specific data requirements within established timelines and budget parameters. We provide all-rounded clinical information services. Our biometrics team is made up of 200 professionals with a breadth of knowledge and rich experience in all clinical projects. 40% of our team members have experience with overseas projects while 35% of them have participated in oncology projects.
With sound structure and training systems, our data management team is experienced in foreign pharmaceutical factories and CROs. Trained to guarantee high project cooperation, reliable delivery quality, and good customer relations, the team is both efficient and professional.
Aspects of Data management and Statistical Analysis functional services:
Biostatistics and Programming services
- Biostatistics consultation
- Clinical development plan and strategies
- Protocol/Trial design
- Statistical Analysis Plans (SAPs)
- Regulatory interactions
- Programming for tables, figures and listings
- CSR/ISS/ISE production
- Annual reports/DSURs
- Data warehousing and Data Integration
- CDISC submission standards, including legacy data conversion
- Observational Studies/RWE
- Data Mining, Meta-analyses
- Data Monitoring Committee support
Data Management Services
- Data base design and development, including the following systems
- Case report form (CRF) design based on CDASH
- IRT databases build-up and navigation
- Medical coding
- Patient Profile Report and Patient Narrative
- DM status report and listings including study specific KPIs and trends
- Study risk monitoring centered quality control
- CTMS database build-up
- Medical monitoring listings Data surveillance and fraud detection