In compliance with ICH-GCP and in accordance with US FDA 21 CFR Part 11 regulations concerning the DM system, our data management and biostatistics services are tailored to fit your clinical trial needs. We employ advanced technologies, optimized processes and professional teams to meet specific requirements of each project. The excellent planning and abundant resources can ensure high quality data with strict timelines and budget constraints.
The following software and Dictionary are used for data management:
- Oracle Clinical
- Clinical Research Data Management System (developed by SCRC)
- WHO DD
- J Review
The software used for statistic analysis includes:
- SAS 9.2
- WinNonlin 6.2
- nQuery 7.0
- MedCalc 11.6
In compliance with ISO 27001, our strong IT system guarantees the safety of data storage and data transfer. We have established the Remote Backup System in Beijing to ensure data safety.
We have designed and implemented an effective quality control system to ensure each step is done in accordance with the high standards of our procedures