What we deliver
- Data management plans, EDC build and validation
- Medical coding (MedDRA, WHODrug)
- Biostatistics: SAP authoring, sample size and randomisation
- Statistical programming in SAS and R
- CDISC SDTM and ADaM datasets, define.xml
- Clinical study reports (CSRs)
Why it matters
- Submission-ready datasets that satisfy MHRA, EMA and FDA
- Faster database lock and CSR delivery
- Senior biostatistician input from day one
