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Biostatistics & Programming

NewEdge Clinical provides R and statistical programming, analysis and reporting services for clinical trial Phase I–IV, HEOR studies.

Develop SAP
Prepare TFL shells
Update SAP and shells
Sign-off SAP and shells

aCRF SDTM annotation
SDTM specifications & mapping
Independent SDTM validation
Pinnacle 21 validation
Create Define.xml & SDRG
Convert to transport files
Dry run & final SDTM transfer

ADaM specifications
Create ADaM datasets
Independent validation
Pinnacle 21 validation
Define.xml & ADRG
Transport files & final transfers

Create CSR-ready TFLs
Independent validation
Data quality & reconciliation
Dry runs & final transfer

DMC charter creation & review
Firewall-protected DMC setup
Pooled & scrambled TFLs
DMC presentations & minutes
sFTP encrypted delivery

Clinical site & subject-level listings
Clinsite.xpt & Define.xml
BIMO Reviewer’s Guide (BDRG)
FDA OSI-compliant documentation