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
Nitendra Agarwal, MD
Internal Medicine
Glen Apseloff, MD
Abuse Liability/Clin Pharm
Sarah Atkinson, MD
Psychiatry Adult/Pediatric
Alina Beaton, MD
Internal Medicine/Pain
Mark Brody, MD
Neurology/AD
Keith Candiotti, MD
Anesthesiology/Pain
Andria Chastain
Psychiatry/Addiction
Andrew Cutler, MD
Psychiatry/Neurology/Addiction
Clay Dehn
Metabolism/NASH/Clin Pharm
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
Ana Fuquay
Alzheimer’s Disease/Neurology
Grant Garbo, MD
Emergency Medicine
Daniel Gruener, MD
Psychiatry/Pain/Addiction
M. Saleem Ismail, MD
AD/Psychiatry/Geriatric Psychiatry
George Konis, MD
Psychiatry/Addiction/Internal Medicine
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
Miranda Porter, PhD
Psychiatry/Neuropsychology
Alexander Prezioso, MD
Obstetrics & Gynecology/Phase 1
Denise Roberts
Pain/NASH/ General Medical
Steve Romano, MD
Drug Development/CNS
Janeen Rosales
Phase 1/Special Populations
Dennis Ruff, MD
Phase 1/Internal Medicine
Sherwyn Schwartz, MD
Endocrinology/NASH
Neil Singla, MD
Acute & Chronic Pain/Anesthesiology
Stephen Thein, PhD
Sleep/AD
Erin Tireman, PsyD
CNS Rater Training, Psychedelics
Daniel Umbricht, MD
Translational Medicines/CNS
Kimberly Vanover, PhD
Drug Development/CNS
Richard Walovitch, MD
Imaging/Pharmacology
Lori Wright
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