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 certainty, 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

Nitendra Agarwal, MD

Internal Medicine/Obesity

Glen Apseloff, MD

Abuse Liability/Clin Pharm

Sarah Atkinson, MD

Psychiatry/Pediatrics

Mark Brody, MD

Neurology/AD

Keith Candiotti, MD

Anesthesiology/Pain

Andria Chastain

Psychiatry/Addiction

Andrew Cutler, MD

Psychiatry/Neurology/Addiction

Clay Dehn, MS

Metabolism/NASH/Clin Pharm/Obesity

Emanuel DeNoia, MD

Phase 1/Internal Medicine

Stacy Dilzer

Clin Pharm/Renal/Hepatic

Bernadette D’Souza, MD

Psychiatry/Addiction

Judith Dunn, PhD

Drug Development/CNS

Angela Eakin, MD

Phase 1/Family Medicine

Ellen Fields, MD

Drug Development/Regulatory

Ana Fuquay, MS, CCRC

Alzheimer’s Disease/Neurology

Holly George, RPH, CCP

Pharmacist/Neurology

Daniel Gruener, MD

Psychiatry/Pain/Addiction

Sharon Hertz, MD

Regulatory

George Konis, MD

Psychiatry/Addiction/Internal Medicine

Romana Kulikova, MD

Neurology/Pediatrics

Luke Kramer

Patient Advocate

David Leiman, MD

Acute & Chronic Pain/Anesthesiology

Suresh Mallikaarjun, MD

Drug Development/Clin Pharm

William Martin, PhD

Drug Development/CNS

Harold Minkowitz, MD

Acute & Chronic Pain/Anesthesiology

Ashley Poole

Psychiatry/Pediatric

Alexander Prezioso, MD

Obstetrics & Gynecology/Phase 1

Denise Roberts, RN

Pain/General Medical

Steve Romano, MD

Drug Development/CNS

Janeen Rosales, MS, CCRC

Phase 1/Special Populations

Dennis Ruff, MD

Phase 1/Internal Medicine

Sherwyn Schwartz, MD

Endocrinology/NASH/Obesity

Adam Smith, PhD, MBA

Psychology/Neurology

Stephen Thein, PhD

Sleep/AD

Daniel Umbricht, MD

Translational Medicines/CNS

Kimberly Vanover, PhD

Drug Development/CNS

Richard Walovitch, MD

Imaging/Pharmacology

Peter J. Weiden, MD

Psychiatry

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

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