Healthy Volunteers
ERG site CPMI routinely conducts Phase I studies that require overnight stays, sometimes up to 40 days.
120-bed
clinical pharmacology unit
800+
studies with normal
healthy volunteers
5,000+
database of normal
healthy volunteers
Phase I studies help researchers determine how a drug works, by understanding its clinical pharmacology. Having conducted over 2000 Phase I studies, ERG is known throughout the industry for excelling in these trials. Most Phase I studies are conducted in normal healthy volunteers (NHV); NHVs are also used as a cohort of a Phase I study in metabolic, neurologic, psychiatric, endocrine, and cardiac disorders. We have access to a wide range of healthy subject profiles, and, whatever your compound, we stand ready to help you explore its clinical pharmacology.
Demonstrated Expertise in Study Designs
- Absolute Bioavailability
- Bioequivalence
- Cardiac Safety, Thorough QT/QTc
- Drug-Drug Interaction
- Elderly Healthy Cohorts in Proof-of-Concept/Proof-of-Mechanism
- ETOH Interaction
- First-to-File
- First-in-Man
- Food Effect
- Patch Irritability
- Pharmacokinetic/Pharmacodynamic
- Relative Bioavailability
- SAD/MAD
- Tasting
Healthy Cohorts in CNS Drug Development
As a neuroscience leader, ERG partners with its clients throughout the CNS drug-development lifecycle, from first-in-man SAD/MAD studies through proof-of-concept/proof-of-mechanism and large Phase III programs; we are also adept at the full suite of clinical pharmacology trials, including drug-drug interaction, food effect, cardiac safety, DDI, TQT, and abuse liability trials.
The industry has been trending toward early signal detection, and complex designs continue to be the norm. ERG has extensive experience running Phase I-IIa trials which include a normal healthy cohort, followed by dosing in patients suffering from various disorders, including schizophrenia, depression, and Alzheimer’s disease. These trials tend to include biomarker measurements such as functional magnetic resonance imaging (fMRI), positron emission tomography (PET) scans, quantitative electroencephalography (qEEGs) and EEGs, cerebrospinal fluid (CSF) sampling, and other specialized procedures. ERG is uniquely qualified to run these trials given its deep bench of early phase experts and its CNS-focused clinical research units.
Industry-Leading Expertise with Healthy Volunteers
Our long-standing staff of fully-trained physicians, pharmacists, nurses, clinical research coordinators, nutritionists, laboratory technicians, and others partner with CNS and non-CNS clients from study design through CSR finalization.
ERG’s Experienced Early Phase Team
Jim Aukstuolis, MD
Maria Bermudez, MD
Wendy Bond, MD
Mark Brody, MD
Stacy Dilzer
Bernadette D’Souza, MD
Daniel Gruener, MD
George Konis, MD
Kenneth Lasseter, MD
Samuel Oberstein, MD
Paayal Patel, MD
Thomas Reilly, MD
Erica Ridolfi
Sherwyn Schwartz,MD
Stephen Thein, PhD
ERG site CPMI hit 97% of their enrollment target for NHV trials within the last year
Targeted Patient Recruitment
With an active database of over 5,000 normal healthy volunteers of all types and profiles, ERG is able to swiftly enroll studies, taking just weeks from contract execution to first patient in (FPI). Since studies may last 40 or more days, we offer both suitable dormitories and spacious recreational areas, with internet access and organized activities that help keep subjects engaged and secure retention.
Spotlight
Stacey Dilzer
- Sought-after operational leader in early-phase execution and study design for healthy volunteer trials
- Expert in the management and supervision of all phase I-IV clinical trials
- Extensive clinical operations career
Maria Bermudez, MD
- Principal Investigator on 100s of Phase I trials in healthy volunteers and special populations
- Principal Investigator at Watson Therapeutics/Teva Pharmaceuticals and Comprehensive Clinical Development, Inc.
- Board Certified by the American Board of Internal Medicine; certified Physician Investigator by ACRP
Case Study: Bioequivalence Trial
Study compared commercial and development formulations (TDH)
- 4-week enrollment period
- 76 subjects enrolled
- 1216 total inpatient nights