Psychiatry

ERG has conducted 600+ clinical studies in schizophrenia and depression.

1,800+

Psychiatry Studies

10

sites with psychiatric expertise

ERG was founded with a focus on debilitating mental health issues—optimizing our investigational sites and patient recruitment strategies to advance important therapies and helping bring dozens of much-needed medicines to market. We stand ready to assist you with your development needs.

Demonstrated Expertise in Key Indications

  • ADHD
  • Anxiety Disorders
  • Bipolar Disorder
  • Eating Disorders
  • Depressive Disorders
  • Obsessive Compulsive Disorder
  • Opioid Use Disorder
  • Post-Traumatic Stress Disorder
  • Schizoaffective Disorder
  • Schizophrenia

Studies from First-in-Man Through Phase IV

ERG has extensive experience in all phases of clinical studies, including Phase I studies with both normal healthy patients and those with psychiatric indications.


Industry-Leading Psychiatric Expertise

ERG staff is headed by industry leaders in all aspects of psychiatry. Our raters average 20 years of clinical experience each and are certified by industry-recognized psychiatric rating experts; back-up raters provide consistency across studies. Critically, both raters and site staff receive extensive training on mitigating placebo response; training that augments sponsor-provided instruction.

ERG’s Experienced Psychiatry Team
Sarah D. Atkinson, MD
Jim Aukstuolis, MD
Robert Billingsley, Jr., MD
Gerald Cephas, MD
Andria Chastain
Bernadette D’Souza, MD
Otto Dueno, MD
Paul Greene, PhD
Daniel Gruener, MD
George Konis, MD
Shenif Ladak, MD
Ashley Poole, CCRC
Erica Ridolfi
Stephen Thein, PhD

Affiliate Psychiatry Team
Evgeny Fink, MD
Paul Miller, MD
Howard Schwartz, MD
Nick Vatakis, MD
Gary Zammit, PhD

Specialized Resources for Psychiatric Research Studies

ERG sites have access to a full suite of neuroimaging for psychiatric studies, including functional magnetic resonance imaging (fMRI), magnetic resonance imaging (MRI), and positron emission tomography (PET) scans. We also have polysomnogram (PSG) equipment on-site, enabling overnight sleep studies without needing to disrupt patients. ERG has expertise conducting electroencephalography/quantitative electroencephalography (EEG EEG/qEEG) studies in psychiatric subjects, as well as other specialized testing such as ophthalmologic exams, gynecological procedures, and surgical implants.

Onsite staff prepare investigational products for all routes of administration, including compounding, encapsulation, and IV infusion. Sites engage in regular mock dosing to ensure that all time points are met, including pharmacokinetics (PK).

We complement our specialized equipment and staff expertise with rigorous quality reviews by full-time quality assurance and quality control staff to ensure optimal outcomes for your study—and ample inpatient beds to accommodate complex study designs and provide the flexibility to separate populations

In a recent rescue study of a schizophrenia therapy. ERG completed study start-up (contracting, regulatory and site initiation) in 48 hours—and was the top-enrolling site in the study.

Targeted Patient Recruitment

The target patient population for psychiatric clinical trials is often misdiagnosed—or even undiagnosed—making these trials challenging to recruit, manage and assess. Sponsors then frequently seek very specific traits, from age and gender to BMI or symptomatology. ERG’s signature patient strategies include sophisticated patient recruitment and retention practices deployed across the entire site network. We begin with large patient databases and local partnerships, then carefully prescreen, screen and enroll to gather the optimal patient cohort for your trial.

Spotlight

Doctor icon

Daniel Gruener, MD

  • Conducted 400 early- and late-phase clinical trials
  • Board Certified, American Academy of Pain Management, American Board of Psychiatry and Neurology
  • Industry-leading researcher in psychiatry, pain, addiction, diabetes and HAL
  • Authored numerous peer-reviewed journal articles and scientific abstracts
Learn More

Project STARR 911

A clinical research collaboration to prevent suicide among those mentally ill patients who contact a clinical study to explore potential enrollment opportunities.

Learn More
Pharmaceutical icon

Placebo Response Mitigation

Continuous training implemented across sites creates an optimal environment for signal detection, minimizing the occurrence of failed studies.

Learn More