CPR’s biometrics excellence stems from our staff’s decades of experience in clinical trials across the world.

The quality of our biostatistics and pharmacokinetic (PK) analysis has gained us a reputation for accuracy and precision.

Data Management Services include:

  • Case Report Form (CRF) development
  • Provision of Data Management Plan (DMP) and Edit Check Specifications
  • e-CRF development and validation using Medrio (www.medrio.com)
    • 21 CFR Part 11 compliant
  • Edit check programming
  • Data cleaning and reconciliation
  • Database exports in Excel and SAS formats
  • Medical Coding (MedDRA and WHO-DD)
 CPR Pharma 2016

Statistical and Pharmacokinetics Services include:

  • Randomisation
  • Provision of code-break envelopes
  • Sample size calculations
  • Statistical Analysis Plan (SAP) development
    Pharmacokinetic analysis using WinNonlin
  • Interim PK analysis for dose escalation decisions
  • Programming of Tables, Listings and Figures (Section 14 and 16.2) for ICH E3 CSR
  • Statistical analysis and reporting
  • Clinical Study Report according to ICH E3
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