Epidemiology & Pharmacoepidemiology Consulting

Capabilities

• Exposure Assessments

  For industrial manufacturers, chemical producers, pharmaceutical developers, and consumer brand owners, Exponent characterizes chemical and biological exposures to evaluate exposure-response relationships. We analyze complex exposure data to deliver defensible risk assessments, guiding strategic decision-making that protects both operations and public health.

  Learn more

• Cluster Investigation Analysis

  Exponent provides sound scientific analysis and cluster investigations using state-of-the-art mapping and statistical tools to characterize the spatial patterns of disease occurrence.

  Learn more

  

• Meta-Analysis for Health Science

  When clients require complex analysis of epidemiological data and health research, Exponent performs meta-analysis to evaluate treatment and exposure effects on health outcomes in a wide variety of contexts.

  Learn more

  

• Biostatistics & Data Science

  For life science firms, chemical manufacturers, and global industrial clients, complex or inconsistent data can jeopardize critical regulatory approvals. We apply advanced biostatistical modeling across clinical, epidemiological, and workplace datasets, curating massive, disparate data into clear, defensible decision-drivers that includes our consultants' substantive knowledge and withstands regulatory scrutiny.

  Learn more

• Cluster Investigations & Safety Signals

  Suspected disease clusters and safety signals can trigger public concern, regulatory scrutiny, and organizational risk. We apply advanced epidemiological methods, mapping, and statistical tools to determine whether observed patterns exceed expected rates. Our epidemiologists evaluate potential environmental or occupational exposures, refine possible safety signals, assess causation and alternative explanations, and translate findings into clear, data-driven insights to support confident decision making.

  Learn more

• Meta-Analysis & Systematic Reviews for Health Sciences

  Conflicting pharmacoepidemiology study results, fragmented clinical research, or disparate occupational or environmental data can delay decisions and increase uncertainty around risk profiles of workplace hazards, community exposures, and consumer and medical products. We conduct systematic literature reviews and meta-analyses to synthesize epidemiological and clinical evidence, evaluate consistency, assess heterogeneity, and identify meaningful patterns in the data.

  By analyzing results across independent studies, we help resolve inconsistencies regarding chemical, environmental, or medical product exposures to generate a more robust understanding of exposure-response relationships and provide clear, evidence-based conclusions. 

  Learn more

• Pharmacoepidemiological Studies

  Navigating the safety and effectiveness of a medical product  — including drugs, vaccines, medical devices, and biologics —  requires rigorous data throughout a product's lifecycle. Prior to market, we analyze real-world data to define disease burden, track the natural history of disease, establish baseline incidence and prevalence, inform or validate clinical endpoint selection, and characterize the background rates of adverse events to optimize safety planning.

  Once a drug or medical product reaches the market, real-world use can reveal new risks, creating potential safety, regulatory, and reputational challenges. We design and conduct pharmacoepidemiological studies using real-world data, including electronic health records and administrative claims databases, to evaluate safety signals, treatment outcomes, and comparative effectiveness, helping you proactively manage risk across the product lifecycle and satisfy obligations to regulators.

  Learn more

• Rx-to-OTC Switch Support

  Our multidisciplinary teams support regulatory and business strategy decisions to transition mature prescription drugs to over-the-counter status. Our experts compile robust Integrated Summaries of Safety (ISS) to satisfy rigorous FDA regulatory submission requirements for New Drug Applications (NDAs), bringing together clinical safety documentation from published observational studies and analysis of adverse events data from postmarketing databases.

  This data-driven lifecycle management approach quantifies risk across specific dose ranges, helping you successfully navigate the regulatory switch process.