Actionable Biomarker Measurements for Early Phase Clinical Development

Biomarkers play a critical role in clinical development by providing early insights into drug safety, efficacy, and mechanism of action from first-in-human trials to Phase III. They help optimize dose selection, identify patient subgroups, and accelerate decision-making, improving the likelihood of clinical success.

ERG site staff are highly trained to meet the specialized demands of using biomarkers to conduct clinical research. With robust onsite processing capabilities in CLIA-waived laboratories and onsite operating rooms, our teams are able to move swiftly toward study endpoints.

ERG Sites with Biomarker Expertise

Specialized Procedures for Biomarker-Informed Clinical Research

Working hand-in-hand with ERG’s experienced sites and researchers, our team can perform specialized testing and procedures to support precise biomarker analysis for data-driven decision-making. Capabilities include:

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 (CSF) Sampling

APOE Genetic Testing

Pharmacokinetic

Metabolic clamps

Euglycemic clamps, etc.

Tracer Methodology / Isotopic Labelling

OGTT & MMTT

Oral Glucose Tolerance Test and Mixed Meal Tolerance Test

Electroencephalogram (EEG)

Specialized Biomarker Testing.

Smarter Early Decisions.

Demonstrated Expertise in Key Indications

As a CRO rooted in neuroscience and metabolic clinical development, our experience spans many indications and patient profiles including:

Alzheimer’s Disease/Mild Cognitive Impairment

Psychiatry

Obesity

Special Patient Populations

Supporting Clinical Development from First-in-Man to Phase III

By integrating biomarkers at every stage of clinical development, drug developers can make data-driven decisions, reduce development risks, and accelerate the path to approval. Our experience spans the clinical development lifecycle including:

Specialized Phase I Units for Biomarker Research

Custom-designed clinical pharmacology research units include private research rooms and dormitories for studies with inpatient stays of 40 or more days. We can screen and randomize large patient numbers and support a wide range of specialized procedures. An on-site PK/PD sample processing lab speeds results, while on-site pharmacies (with a bolted safe for Schedule I drugs) can compound drugs, including capsules, tablets, and oral solutions and suspensions.