Scientific Leadership Team

Industry-Leading Expertise for Every Phase of Your Trial

From leading drug development experts to principal investigators and operational managers, ERG has assembled a team of industry leaders whose expertise spans multiple therapeutic areas and over 50 specific indications across all stages and types of clinical trials. We offer their knowledge to sponsors and clinical research organizations, helping identify opportunities and avoid potential pitfalls as you plan and implement your clinical trial.

ERG demonstrates medical and operational excellence through our Scientific Leadership Team

ERG has formed a Scientific Leadership Team, comprised of internal and external industry experts across all the therapeutic areas in which the organization focuses and upon which it has built its reputation. ERG’s Scientific Leadership Team holds meetings twice weekly (more frequently as needed) to collect Scientific & Operational input on new trials presented to ERG, with the intent of providing meaningful feedback to our sponsors and CRO partners. This process allows us to more carefully evaluate the feasibility of the studies contemplated across all ERG site locations to ensure we are accepting trials, with a high degree of certainly, on which we believe we will perform successfully. While success is never guaranteed in the execution of any clinical trial, our goal at ERG is to gather input from all experts, anticipate what challenges we may face, and then minimize the risk to both the trial and to our reputation by recommending only those sites we feel are well-suited based upon the information available to us at that time.

SLT Industry Experts

Dr. Suresh Mallikaarjun

Drug Development / Clin Pharm

Dr. Glen Apseloff

Abuse Liability / Clin Pharm

Dr. William Martin

Drug Development / CNS

Dr. Mark Brody

Neurology / AD

Dr. Stephen Thein

Sleep / AD

Dr. Nella Green

Infectious Disease

Stacy Dilzer

Clin Pharm / Renal/Hepatic

Luke Kramer

Patient Advocate

Janeen Rosales

Phase 1 / Special Populations

Dr. Dennis Ruff

Phase 1 / Internal medicine

Dr. Emanuel DeNoia

Phase 1 / Internal medicine

Dr. Richard Walovitch

Imaging / Pharmacology

Dr. Keith Candiotti

Anesthesiology / Pain

Dr. Harold Minkowitz

Acute & Chronic Pain /Anesthesiology

Dr. David Leiman

Acute & Chronic Pain / Anesthesiology

Dr. Neil Singla

Pain

Denise Roberts

Pain / NASH / General Medical

Dr. Sherwyn Schwartz

Endocrinology / NASH

Clay Dehn

Metabolism / NASH / Clin Pharm

Dr. Paul Michael Ramirez

Ratings Expert, Rater Training

Dr. Erin Tireman

CNS Rater Training, Psychedelics

Dr. Andrew Cutler

Psychiatry / Neurology /Addiction

Dr. Judith Dunn

Drug Development / CNS

Dr. Steve Romano

Drug Development / CNS

Dr. Daniel Umbricht

Translational Medicine / CNS

Dr. Kimberly Vanover

Drug Development / CNS

Dr. Daniel Gruener

Psychiatry / Pain / Addiction

Andria Chastain

Psychiatry / Addiction

Dr. Bernadette D’Souza

Psychiatry / Addiction

Dr. Sarah Atkinson

Psychiatry Adult / Pediatric

Dr. James Whalen

Psychiatry / Addiction

Dr. M. Saleem Ismail

AD / Psychiatry / Geriatric Psychiatry

Ashley Poole

Psychiatry / Pediatrics

Protocol Design and Review

A strong protocol sets the foundation for ensuring patient safety, collecting high-quality data efficiently, reporting results promptly, and supporting future regulatory requirements. ERG harnesses deep knowledge of specific therapeutic areas to help you design the optimal protocol for your clinical trial. Indeed, our rigorous review process includes staff from any discipline that will “touch” that protocol, from principal investigators and clinical operations staff to regulatory, recruitment, pharmacy, and quality assurance personnel. This service is provided at no cost as a professional courtesy. We can also connect you to professional medical writers—often from among our advisors—who we can recommend as paid resources to write your protocols.

Vendor Resourcing

Vendor selection can be daunting. ERG can help. Having worked with most established clinical research vendors, we bring hands-on knowledge. We are happy to recommend vendors based on your specific program needs—including many of our own consultants—or to simply offer insights into vendors you are considering.

  • Rater Training Services
  • Centralized Core Laboratory Services (ECG, PSG, EEG, qEEG, Actigraphy)
  • Medical Writing Services
  • Medical and Clinical Monitoring
  • Project Management
  • Niche CROs
  • Other Study Specific Services

Let us help you set up an Advisory Board

Tell us the therapeutic area in which you are working, and we will gather the appropriate advisors for a virtual or live meeting. We can help with overall development strategy from Pre-IND to Phase IV, including potential indications, types of studies to consider, protocol design and implementation, as well as vendor selection. We can also provide review and feedback on current studies and protocols. We have experience with populations of all ages from pediatric to geriatric. Our areas of expertise include, but are not limited to, CNS (psychiatry and neurology), Addiction (including HAL studies), Pain/analgesia, Sleep, GI (including NASH), Endocrinology (diabetes, thyroid, etc.), Clinical pharmacology and toxicology, Phase I (NHV, special populations, SAD/MAD, hepatic/renal/cardiovascular safety, etc.).

Working closely with you, we will:

  • Set the Advisory Board’s goals and strategy
  • Plan appropriate timelines
  • Identify the optimal moderator and board members
  • Develop detailed meeting agendas
  • Develop meeting budgets and manage costs
  • Ensure regulatory compliance
  • Determine the length of engagement
  • Report meeting outcomes
  • Manage all logistics