Biostatistical consulting

Metronomia, your choice for biostatistical consulting when:

  • You seek robust statistical designs for your clinical development plan (CDP), no matter how challenging or novel
  • Data expertise is required for strategic planning and decision making, and the advancement of your CDP
  • Statistical experts with extensive FDA and EMA experience are sought for regulatory interactions, independent expert statements, and inspection and filing readiness activities
  • Conventional solutions on conventional timelines cannot be afforded and must be substituted by ingenuity, speed and flexibility

Metronomia, the credible, innovative and trusted partner of pharmaceutical, biotech and medical device Sponsor companies for over 30 years. Trust us for competent statistical consulting and data science support.

Services include:

  • Statistical planning: modelling & simulation, sample size estimation, estimand and intercurrent event specifications
  • Navigation of regulatory requirements and guidelines via expert advice and representation
  • Advanced statistical methods: adaptive designs, interim decision making tools, adaptive dose finding, Bayesian methods, complex modelling, handling of missing data
  • Compliance and Inspection Readiness: Statistical training, audit/inspection preparedness and support
  • Filing Readiness: data integration strategies and submission activities
  • Data quality monitoring strategies & technologies
  • Independent data monitoring activities
  • Statistical, medical and scientific writing, read more

“After 30 years of biostatistical consulting, we can honestly say that we are proud of our achievements. We speak your language and are eager to help with any biostatistical, regulatory or clinical issue that may arise during product development. We welcome new challenges.”

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