Biostatistics

Exponent provides sound and insightful statistical analyses in the following areas:


  • Medicine, pharmacology, medical devices, and diagnostics
  • Public health, epidemiology, and environmental health
  • Biotechnology, bioinformatics, statistical genetics, and genomics

Exponent statisticians in the Health Sciences and Statistical & Data Sciences practices have extensive experience in statistical/biostatistical methods and the application of these methods to a wide range of applied and research health studies, including clinical investigations, epidemiologic studies, public health evaluations, health economics analyses, and other outcomes research. Our Ph.D.-level statisticians, including several former senior faculty members at leading universities, have over 100-years of combined professional experience and can provide sound and insightful statistical analyses, as well as guidance in health study design and questionnaire/survey instrument development.

Exponent statisticians also have extensive data analytic expertise, especially in the creation of comprehensive and cohesive databases via the integration of various and disparate data sources, such as claims, registry, and electronic clinical, administrative, and economic data. These databases are used to develop integrative models in support of advanced research and statistical evaluations. Exponent’s statisticians have also played a significant role in the risk assessment of various occupational and environmental exposures, as well as a wide range of issues in medicine, pharmacology, public health, and biotechnology.

Medicine, Pharmacology, Medical Devices, and Diagnostics

Clinical trials are the gold standard for convincing consumers and regulatory bodies that a new therapy works. Designing powerful trials that effectively and accurately measure both efficacy and safety can be challenging. Delays in gaining approval for a product are expensive: each additional day that a drug spends in clinical development can cost a company as much as $600,000 in lost revenue for a niche drug, and $8 million for a blockbuster. On the other hand, not detecting uncommon but harmful side effects or failure mechanisms can cost billions in regulatory compliance and potential litigation expenses.

Our experienced statisticians assist in the design and analysis of studies to gather the most accurate and powerful information throughout all stages, from discovery to marketing. This includes dose-ranging, pharmacokinetic, pharmacodynamic, drug interactions, safety and efficacy studies in nonclinical and phase 0–II clinical trials in the developmental stage, efficacy, and safety studies in phase III clinical trials in the approval stage; quality control studies in the production stage, and final evaluation of adverse events in post-marketing studies.

Exponent assists pharmaceutical, biotechnology, and medical device organizations in:


  • Designing powerful and effective clinical trials, using completely randomized, block randomization, or adaptive designs
  • Analyzing nonclinical, 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

Public Health, Epidemiology, and Environmental Health

Statistical analyses of public health and environmental health data are critical to assessing risks and understanding whether policies, initiatives, and regulations are appropriate and successful. Exponent statisticians are experienced in designing and analyzing epidemiological and environmental health studies. We provide proven, cost-effective, scientifically defensible, and realistic assessments and solutions to complex environmental issues. Our services include ecological and human health risk assessment, population studies, toxicology dose-response studies, mode-of-action assessments, and epidemiology studies of public health policies.

In biomedical research, statistical methods in biotechnology can assist in finding candidates for gene alleles that cause or influence predisposition to disease, which may lead to new therapies for those diseases. In agricultural research, this work can improve the yield or resistance to diseases of crops and farm animals. Our staff assists in the evaluation of micro-array data, probabilistic evaluation of genetic patterns, computational genomics, and interpretation of DNA evidence.

Biotechnology Research

In biomedical research, statistical methods in biotechnology can assist in finding candidates for gene alleles that cause or influence predisposition to disease, which may lead to new therapies for those diseases. In agricultural research, this work can improve the yield or resistance to diseases of crops and farm animals. Our staff assists in the evaluation of micro-array data, probabilistic evaluation of genetic patterns, computational genomics, and interpretation of DNA evidence.

Professionals

Knowledge