Clinical Research


Testing of candidate drugs in humans is conducted to evaluate safety and the efficacy in treating, preventing, or diagnosing a specific disease or condition. The most important consideration in these studies is the safety of trial participants. Human testing occurs in FDA-supervised, phased clinical trials, along with further assays to characterize absorption, distribution, metabolism, and excretion (ADME) and toxicity associated with the lead candidate(s) that made it through earlier phases of testing. Show more

Clinical trials can take many forms and increasingly enroll a range of different populations. However, patient populations may be stratified in clinical trials when data suggest that a particular group may respond better to a specific treatment regimen. Generally, there are three or four phases during drug development. Phase 0 is increasingly included for investigational new drugs (INDs). This phase involves testing of subtherapeutic doses on a small number of subjects to confirm that the animal studies are valid in humans.

If a drug candidate passes Phase 0, the clinical trial will progress to Phase I, designed to evaluate drug safety, side effects, and dosage range in a small cohort. Phase II usually extends the trial to a larger cohort and compares the putative drug to a placebo. Typically, Phase III broadens the scope of Phase II to more study subjects, often with different populations, and includes comparisons to one or more existing treatments as well as further monitoring and evaluation of adverse events. Phase IV involves population studies after the market release of a new drug.Show less

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Feature Articles

Bio-Rad's Drug Discovery and Development Workflow Solutions
Learn how Bio-Rad's products align with your drug discovery and development workflows  Download

Monitoring Antibody Immune Responses against Biotherapeutic Drugs

Solutions for Clinical Research

Critical Raw Materials for Clinical Diagnostics

Critical Raw Materials for Clinical Diagnostics

Browse a selection of critical raw materials for developing human diagnostics such as inflammation markers, tumor antibodies, and antigens for common tumor types.

Diagnostic Antibodies
Acute Phase Proteins

Protein Analysis and Quantitation

Protein Analysis and Quantitation

Use our comprehensive protein analysis tools for fast, reproducible quantitation of proteins, including antibodies, with built-in controls and validation steps to meet regulatory needs.

GS-900™ Calibrated Densitometer and Regulatory Tools (CFR validated for cGMP)
Western Blotting Reagents and Equipment
Multiplex Immunoassays



Choose from our extensive range of antibodies designed for in vitro diagnostic clinical assays or utilize our custom antibody services including custom manufacturing.

Antibodies by Application
Antibodies by Target Species
HuCAL® Custom Antibody Services

Autoimmune Kits and Instruments

Autoimmune Kits and Instruments for In Vitro Diagnostics

Explore a range of enzyme immunoassay kits and automated instrumentation specifically designed and approved for autoimmune testing and diagnosis in clinical trials.

Systemic Autoimmune Testing
Gastrointestinal Autoimmune Testing

Additional Methodolgies and Research Within Drug Discovery and Development
  • Biochemical and Cellular Assays

    Biochemical and Cellular Assays
    In vitro and in vivo discovery approaches with high sample throughput and high-content analysis to characterize biological responses.

  • Biomarker Discovery

    Biomarker Discovery & Validation
    Biomarker monitoring across drug discovery, development, and clinical stages is key to defining drug effects.

  • Biologic Development

    Biologic Development
    Biologic development brings patients closer to personalized medicine to treat health problems.

  • Biosimilar Development

    Biosimilar Development
    Biosimilar development requires physicochemical and functional characterization to ensure similarity.

  • Cancer Immunotherapy Development

    Cancer Immunotherapy Development
    Learn about trends in cancer immunotherapy development, such as CAR-T, and tools for genomic, cellular, and proteomic research.

  • CRISPR Gene Editing

    CRISPR Gene Editing
    CRISPR enables researchers to edit their desired target genes efficiently and accelerate drug development.

  • Viral Vector Vaccine Development

    Viral Vector Vaccine Development
    The COVID-19 pandemic opened the door to expedited vaccine development using new technologies and therapies that have traditionally been used in other applications.