Services | Biostatistics

Statistics - that's where we come from and that's why we put so much passionate emphasis on it.

Metronomia offers the complete range of biostatistical services, performed by a well-trained team of statistical programmers and industry-experienced biostatisticians. In depth experience in a range of therapeutic areas paired with profound understanding of ICH GCP, regulatory requirements and CDISC standards ensure highest biostatistical quality throughout all stages of clinical development.

Our services

  • Statistical planning of clinical trials with sample size calculation in accordance with ICH E9 and other ICH, CPMP or FDA guidelines and recent developments in biostatistics
  • Deployment of non-mainstream statistical methods where suitable (e.g. MCP-Mod, Bayes methods, CRM, propensity score matching, simulation)
  • Attending meetings with regulatory bodies
  • Participation in DSMBs
  • Statistical Analysis Plan including production of mock-up tables and listings
  • Defining and generating CDISC SDTM and ADaM datasets (including annotating CRFs and generating define.xml)
  • Statistical programming, including set-up of analysis data sets and programming tables, figures and listings
  • Statistical analysis, blinded and unblinded interim analyses
  • Statistical support for AMNOG dossiers (e.g. indirect comparisons, propensity score based matchings)
  • Meta-analysis
  • Pharmacoeconomic analysis
  • Integrated clinical study reports
  • Randomization (including central dynamic randomization via IWRS)

Standards in statistical programming

  • Analysis datasets created according to sponsor specifications and/or industry standards, i.e. CDISC standards
  • Comprehensive Good Programming Practices implemented in our set of SOPs 
  • Detailed program QC/validation plan covering all aspects of program validation
  • SAS® macro validation in line with regulatory requirements and industry standards
  • Comprehensive library of validated SAS® macros and SAS program modules for standard statistical analysis and output including analysis of lab data, adverse events, figures and graphs 
  • Extensive use SAS® ODS functionality to generate enhanced and easily readable output

Statistical systems

  • SAS® (version 9.1.3, 9.3 and 9.4 and 8.2 for archiving purposes)
  • StatXact® (for exact statistical methods)
  • nQuery Advisor® (for sample size calculation)
  • R® (for statistical programming and analysis)
  • Comprehensive library of validated SAS® programs and macros
  • IWRS system for central, dynamic randomization