From methodology to CDISC deliverables.
Statistical analysis plan, randomisation, interim and final analyses. CDISC standards on 100% of our studies since 2014.
Statistical methodology end to end
Statistical Analysis Plan (SAP)
Drafting of the SAP aligned with the protocol and ICH E9 / E9(R1) adaptive design guidelines.
Sample size calculation
Rigorous sizing based on primary and secondary endpoints, with justification for the regulatory dossier.
Centralised randomisation
Generation of the randomisation list, allocation sequences, stratification and blinding management.
SAS analyses
Programming in a validated SAS environment per 21 CFR Part 11, with independent review and double programming.
CDISC standards
Production of SDTM, ADaM datasets and define.xml compliant with EMA / FDA submissions.
Statistical report
Drafting of the final statistical report (CSR appendices) and tables, listings and figures (TLF) per sponsor templates.
Everything you receive at study end
Methodological documents
- Statistical Analysis Plan (SAP)
- Randomisation list
- Interim report (DSMB)
- Biostatistical protocol amendments
Datasets & programming
- Annotated SDTM datasets
- ADaM datasets
- Archived SAS programs
- define.xml & aCRF
Reports & analyses
- Final statistical report
- TLF (tables, listings, figures)
- Randomisation report
- DSMB outputs
Need a biostatistics expert?
Sample sizing, methodology or end-of-study analysis — let's talk.