BIOSTATISTICS & STATISTICAL PROGRAMMING

The affordable yet robust bio-statistical solution from study planning to final reporting & interpretation. Includes but is not limited to sample size calculation, SAP development, TFL programming development, validation & review, and statistical report.

We offer CDISC compliant statistical programming solutions for analysis, reporting, and regulatory submission of clinical data.

Below is the core biostatistical and statistical programming services that we offer:

  • Statistical Analysis Plan and mock shell development
  • Statistical Inputs to the Protocol
  • Sample Size Calculation
  • Generate Randomization Schedule
  • Prepare Unblind/Code Break Envelopes
  • TFL Programming Development & Validation
  • TLF Review
  • Statistical Report
  • Statistical Input to CSR
  • SDTM Programming
  • Analysis Datasets ADaM Programming
  • SDTM Annotated eCRF
  • PK Modeling Dataset
  • ADaM Reviewer’s Guide