Biostatistics

No matter where you are in the process of product development and regulatory approval, FMD K&L has the biostatistical experience and solutions required to help bring your product to market. With an efficient organizational structure designed to promote high quality standards, we have garnered a group of broadly experienced biostatisticians with in‐depth expertise in various therapeutic areas. Our biostatistical services span the entire life cycle of drug development and approval. We assist Sponsors of pharmaceutical, biotechnology, and medical device companies in navigating these complicated and dynamic processes and guide them to product approval.  The services we provide include: 

  • Clinical Development Planning 
  • Power / Sample Size Estimation 
  • Protocol Development 
  • Statistical Analysis Planning 
  • Randomization Scheduling 
  • Interim Analysis / DMC 
  • Annual or Periodic Reporting 
  • Statistical Modeling / Exploratory Analysis 
  • Statistical Reporting and Publications
  • Clinical Study Reporting
  • ISS / ISE