Identifying actionable biomarkers is part of a comprehensive strategy for customized medicine—and a key to the revolution coming to healthcare delivery.


sites with biomarker expertise

Biomarkers have become a critical tool in speeding the success of clinical research trials, enabling researchers to precisely pinpoint target patient populations, inclusion and exclusion criteria, and optimal trial endpoints. ERG’s extensive experience testing biomarkers in diverse therapeutic areas helps streamline this process, accelerating the path to approval.

Demonstrated Expertise in Key Indications

  • Alzheimer’s disease/Mild Cognitive Impairment
  • First-in-man studies
  • Psychiatry
  • Special patient populations

Studies from First-in-man to Phase III

  • Bioequivalence
  • Food Effect
  • Phase IB
  • Phase II/POC
  • Phase III
  • PK/PD

Biomarker-Specific Expertise

ERG site staff are highly trained to meet the specialized demands of the implementation of biomarkers in clinical research. Using these skills, they conduct a wide range of testing: onsite cerebrospinal fluid (CSF) sampling and serial CSF sampling, APOE genetic testing, polysomnography (PSG), quantitative electroencephalography (qEEGs) and EEGs, evoked potential testing, infusions, and serial pharmacokinetic (PK) testing. With robust onsite processing capabilities in CLIA-waived laboratories and onsite operating rooms, they are able to move swiftly toward study endpoints.

Specialized Procedures for Biomarker Clinical Research

  • Positron Emission Tomography (PET)
    • Receptor, Enzyme, Metabolic Ligands
  • Magnetic Resonance Imaging (MRI)
    • BOLD fMRI, ASL, MRS, DTI, hi-res Structure
  • Magnetoencephalography (MEG)
  • Electrophysiology
    • qEEG, ERP, eye movements, PPI, PSG, Actigraphy
  • Cognition
    • Cognitive Activation Paradigms (e.g. MMN)
  • Brain Activity Probes
    • Neuropharmacologic Challenge vs. Ketamine
    • Neuroelectromagnetic Stimulation (e.g. rTMS)
  • FibroScan®
  • Cerebral Spinal Fluid
  • APOE Genetic Testing
  • Pharmacokinetic

Specialized Resources for Biomarker Research

Custom-designed clinical pharmacology research units include private research rooms and dormitories for studies of 40 or more days. We can screen and randomize large patient numbers, and support a wide range of specialized procedures, including cerebrospinal fluid (CSF) sampling; electroencephalography (EEG); imaging such as positron emission tomography (PET) scan, computerized tomography (CT) scan, magnetic resonance imaging (MRI), functional magnetic resonance imaging scan (fMRI), and DEXA scan; driving simulation; and experimental pain modeling. An onsite PK/PD sample processing lab speeds results, while onsite pharmacies (with a bolted safe for schedule Ⅰ drugs) can compound drugs, including capsules, tablets, and oral solutions and suspensions.

Biomarkers are critical to delivering truly personalized medicine

Biomarker Infographic


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Mark Brody, MD, CPI

  • Principal Investigator on 180+ trials
  • Nationally recognized expert in Alzheimer’s disease (AD)
  • Founder of one of America’s largest clinical research facilities specializing in AD
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