DM and Biostatistics
Our team is dedicated to providing industry-standard services in compliance with US FDA 21 CRF Part 11 requirements. We have a deep understanding of regulatory expectations to meet the needs for both global and regional clinical projects.
Our well-trained data management team specializes in customizing strategies to deliver high quality and efficient data management solutions.
We understand that the integrity of the clinical data is key to a successful project. WuXi AppTec C&R emphasizes transparency and accountability, as well as speed and accuracy – from database setup to database lock – while ensuring that all standard operating procedures and regulatory requirements are strictly adhered to.
WuXi AppTec’s data management services include:
- E-CRF and P-CRF design
- Database design and setup
- Double data entry
- Data validation
- Data discrepancy management
- Database QC
- Blinded Data Review
- Medical coding
- AE reporting and SAE reconciliation
- Electronic Data loading
Biostatistics and Programming
Our biostatisticians have extensive knowledge of clinical study design, statistical methodologies, and regulatory requirements to offer tailored consulting expertise. And working closely with the biostatisticians, the clinical teams and clients are experienced statistical programmers who provide high-quality analysis and timely reporting of study results.
- Customized statistical analysis options include:Protocol design
- Sample size estimation
- Randomization and drug repackaging
- Statistical analysis plan and mockup tables
- SDTM conversion
- Statistical programming and TLF generation
- Interim analysis and independent data monitoring committee (IDMC)
- ISS and ISE
- Statistical analysis report
Our data management, biostatistics, and programming teams are also up to date with the current industry submission standards, e.g., STDM and ADAM. Capabilities include mapping the data into the CDISC standards to meet the requirements of regulatory authorities.