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Consulting Services

Kelly Statistical Consulting has extensive experience in the application of sound statistical methodology to diverse application areas.  We can assist you in designing your study to ensure that the appropriate variables are measured in the most precise and accurate manner and that the best, most powerful statistical analysis will be used to improve your results and save you time and money.

Our philosophy is to build long-term relationships by ensuring client satisfaction.  Our clients depend on us for accurate and insightful advice in a timely manner.  Frequent and effective communication is our practical approach to ensuring that we are meeting our clients’ needs.  Our clients have trusted us with their consulting needs for the following key reasons:

  • Quick response times.
  • Results explained in non-technical, understandable language.
  • Personalized approach with on-going communication.
  • Solutions specific to the problems at hand.
  • Compliance with FDA and ISO standards.
  • Extensive theoretical research and applied industry experience.

Medical devices and pharmaceuticals:

Medical Devices and Pharmaceuticals

A good study design for investigating medical devices and pharmaceuticals is key to ensuring that the most accurate and powerful information is gathered, while exposing the fewest subjects to potentially harmful effects. We are accomplished researchers and practicians in the design and analysis of in-vitro, in-vivo, animal, and phase I-III clinical studies, including dose-ranging, pharmacokinetic, pharmacodynamic, drug interactions, safety and efficacy, and quality control studies.We assist pharmaceutical and medical device organizations in:

  • Designing powerful and effective clinical trials, using completely randomized, block randomized, or group sequential designs (with interim analyses)
  • Writing study protocols, Statistical Analysis Plans, and Clinical Study Reports
  • Analyzing pre-clinical, clinical trial, and quality control data
  • Assisting in the submittal of new drug applications (NDAs), pre-market approvals (PMAs), 510(k), and product development protocols (PDPs) to the FDA

Example Projects:
Are two drugs better than one?
How can an ANSI standard for assessing accuracy be extended to a new type of device?
Is the New Zealand strain-specific meningococcal disease vaccine effective?

Epidemiology and public health studies:

Epidemiology and Public Health Studies

Statistical analyses of epidemiologic and public health data are critical to assessing risks and understanding whether policies, initiatives, and regulations are appropriate and successful. Kelly Statistical Consulting is experienced in designing and analyzing epidemiological and public health studies. Our services include ecological and human health risk assessment, toxicology dose-response studies, mode-of-action assessments, and epidemiology studies of public health policies.

Example Projects:
Is the New Zealand strain-specific meningococcal disease vaccine effective?
Is naturally-occurring asbestos a risk factor for mesothelioma?

Conservation and ecological investigations:

Conservation and Ecological Investigations

Proper statistical design and analysis of conservation and ecological studies contributes scientific rigor and credibility to their results.  Kelly Statistical Consulting has experience in estimating population sizes and assessing the factors that affect the health of endangered species.  In addition, we have assisted with studies to assess population demographics, population size, genetic variability, phylogenic relationships and preferred habitat and food in species such as the humpback whale, black rails, California sheephead, junko (a rare sparrow), warblers, buckwheat, vole, baleen whales, skinks, New Zealand crabs, otters, fungi, the Maud Island frog, and others.

Example Projects:
How many bat and bird fatalities are caused by wind turbines?
How can researchers avoid the regression fallacy in observational ecological studies?
Do human-caused sounds affect the health of marine mammals?