The clinical data collection process
We devise a full statistical analysis plan for your clinical study, from planning, analysis to reporting. The process begins with:
- Case Report Form (CRF) design and development of the eCRF database, including integration from third party sources, central laboratory, central ECG, electronic Patient-Reported Outcomes (ePRO).
- Data collection proceeds with continuous data management and data cleansing, with electronic and manual checks on the data to detect inconsistencies. Serious Adverse Events (SAE) are captured in the database.
- Medical coding is supported by built-in eCRF reports and targeted data listings generated and validated by Simbec-Orion group programmers. All programming is performed in SAS® under Git version control ensuring a reliable code base.
Adaptive clinical trial analysis
Our clinical data management team customise each tool to the specific study during set-up to ensure they are live prior to First Patient In and are described in the respective specifications and Study Plans. Statistical reporting is adapted to individual client requirements, providing an accurately tailored clinical trial data management service.