Submission-ready datasets, programmed alongside your study

What we do

Regulatory data programming is where clinical and preclinical programs most often lose time. CDMP runs it in parallel with study conduct rather than after lock: SDTM domains and ADaM datasets take shape as data accumulates, and preclinical findings are harmonized to SEND as they are captured. When the database locks, your standardized datasets, define documents, and validation output are already substantially complete.

On the statistics side, our biostatisticians and programmers cover the analytical lifecycle — from analysis planning through final tables, listings, and figures — working in SAS and R.

What's included

• CDISC SDTM: domain mapping, controlled terminology, trial-design datasets, and annotated CRF.
• CDISC ADaM: analysis datasets, ADSL, derivations, and traceability to SDTM.
• SEND: preclinical findings and trial-design domains harmonized to SEND with controlled terminology.
• Validation: conformance checking and issue triage against published CDISC/SEND rules; define.xml and reviewer's guide.
• Biostatistics: sample size and power support, statistical analysis plan input, and interim/DSMB analysis support.
• Statistical programming: production and QC of tables, listings, and figures in SAS and R; ad-hoc analyses.
• Submission support: dataset packaging and documentation for regulatory filing.

One team, from capture to define.xml

The programmers building your datasets sit with the people who built the EDC and ran conduct. Mapping decisions are made with full knowledge of how the data was collected and coded — which is why parallel programming actually holds up at submission.