Biomarkers

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

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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
  • SAD/MAD

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.

ERG’s Experienced Biomarker Team

Maria Bermudez, MD
Mark Brody, MD
Daniel Gruener, MD
George Konis, MD
Kenneth Lasseter, MD
Hernan Salazar, MD
Sherwyn Schwartz,MD


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®

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

Targeted Patient Recruitment

ERG boasts an active database of over 215,000 patients of all types and ages—including specialized populations and normal healthy volunteers, enabling us to swiftly enroll the precise patient profile in which you want to examine biomarkers. We identify willing volunteers that meet your specifications (postmenopausal women or low testosterone men, the elderly or the obese or smokers, people with diabetes, NASH, high cholesterol, high blood pressure or nearly any other condition), then screen and recruit them in record time—taking just weeks from contract execution to first patient in (FPI).

Spotlight

Doctor icon

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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