Biostatistics

Our biostatistics team consists of statisticians with postgraduate or PhD academic qualifications and experience in many demanding Phase I, II and III analyses and reporting, as well in reporting for regulatory submissions (e.g. for FDA). They can undertake all the statistical work required for a clinical study, including 

  • Study inception and set-up: study design, sample size estimation, protocol writing / protocol review, study randomization including randomization plans, unblinding plans etc.
  • Elaboration of Statistical Analysis Plans (SAP), TLF specifications, mock TLFs
  • Statistical data quality audit
  • Statistical Programming in SAS or R, for analysis, TLF generation, including CDISC/ADAM datasets, and applying formal risk-based processes for testing, verification, and validation.
  • Participation in meetings such as blind review meetings and data review meetings
  • Preparation of Statistical Reports and Clinical Study Reports (in collaboration with medical writers) following ICH guidelines.
  • Preparation of dossiers for regulatory submission, including CDISC datasets and required documentation (SDTM annotated CRFs, CSDRG and ADRG reviewers guide etc)
  • Scientific support during the regulatory submission review and approval phase.
  • Exploratory data analyses
  • Meta-analyses
  • Machine learning algorithms for data exploration



All statistical work is done according to detailed SOPs applying the ICH guidelines (E3, E8, E9, Q9) and including detailed document specifications for plans and reports, QC checklists, controls and documented controlled quality records for plans, reports and programs.

The following ICH guidelines are applied:

  • ICH E3: CPMP/ICH/137/95, ICH Topic E3 Structure and Content of Clinical Study Reports
  • ICH E6 (R2): EMA/CHMP/ICH/135/1995, ICH E6 (R2) Guideline for good clinical practice
  • ICH E8 (R1): EMA/CHMP/ICH/544570/1998, ICH guideline E8 (R1) on general considerations for clinical studies
  • ICH E9: CPMP/ICH/363/96, ICH Topic E9 Statistical Principles for Clinical Trials
  • ICH E9 (R1): EMA/CHMP/ICH/436221/2017 Addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
  • ICH Q9: Quality risk management - Scientific guideline