Biostatistics is a crucial field that involves the design, analysis, and interpretation of data for studies at all phases of development.  Prior to the planning of any study protocol statistical analysis is required to justify the necessity, size, scope and cost of taking an innovation into the development Phases. We have the experience to support investigators to whatever level of the pharmaceutical business they envision.

Biostatistical Analysis solutions include:

  • Design and sample size calculations of pre-clinical and clinical trials; including protocol reviews and co-authoring
  • Classical and population PK/PD analysis
  • Analysis of all types of data from pre-clinical, clinical and epidemiological trials.

Should you decide to expand into a pharmaceutical company, you may need our assistance to connect you with people to handle the following protocols:

  • Study Randomization
    • Parallel-group – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.
    • Crossover – over time, each participant receives (or does not receive) an intervention in a random sequence.
  • Data Monitoring Committee: independent statistician for the DMC and/or DMC analysis
  • Envelope-breaking; at the end of each study the blind is removed and the treatment groups are statistically analyzed for percent and magnitude of difference.
  • Clinical study report review and programming of case narratives
  • Interim analyses and definition of stopping rules
  • Pooling of studies, including safety and efficacy summaries for regulatory submissions