Related services

• Drug development consultancy
• Regulatory affairs
• Clinical pharmacology unit
• Bioanalysis and drug metabolism
• Clinical data management
• Medical writing
• Pharmacokinetics and pharmacodynamics

Early stage biometrical involvement ensures that meaningful clinical trial outputs are produced, enabling conclusive statistical analysis. Xendo’s biometricians/statisticians and statistical programmers use SAS or custom made software to process clinical trial data. We ensure that the timelines from last patient visit to database lock and statistical report are as short as possible.

Contact biometrics
Jelle Hempenius, senior director business development
-    Telephone: +31 (0)50 304 80 04
-    Email: jelle.hempenius@xendo.com

Scope of services biometrics

• Statistical Analysis Plan (SAP)
• Randomization and blinding
• Sample size estimation and power calculation
• Statistical writing
• Analysis populations (ITT, PP and Safety)
• Performance interim statistical analysis
• Coding of adverse events and medical history using MedDRA
• Safety and efficacy analysis
• Statistical evaluation of primary and secondary endpoints
• Import of external data