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Clinical Protocol Experts

The following experts are available as clinical protocol consultants and clinical protocol expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Clinical Protocol - A medical protocol intended to ensure and evaluate the efficacy of a new medical device and/or procedure. It also includes analysis of clinical data to document the protocol and establish its effectiveness and safety for the FDA.

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Clinical Protocol Experts
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Expert in Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination ... See full profile

Minnesota (MN), USA

Expert in Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials ... See full profile

California (CA), USA

Expert in Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing the ... See full profile

Brussels, Belgium

Expert in Clinical Development, Orphan Drugs, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", ... See full profile

Siena, Italy

Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business practices, IP
Expert has been the CEO or chairman of 7 medical device companies in 4 countries - 4 public, 3 private, and has been a member of the Board of Directors of 8 companies. He is an expert in all areas of general and specific management of a medical device ... See full profile

Minnesota (MN), USA

Expert in Accident Reconstruction, Biomechanical, Mechanical, and Neuroelectrical Medical Device Engineering.
Expert understands brain, spinal and orthopedic biomechanics and has analyzed hundreds of cases to determine the causation of injuries sustained by drivers, workers and citizens. He has performed biomechanical research using cadaveric models to ... See full profile

Texas (TX), USA

Expert in Allergy Immunology and Clinical Lab Immunology
Expert has a varied professional life. He has a busy private practice focused on hypersensitivity and immune disorders and asthma. He has unusual experience and recognition in dealing with food allergy of all types, including peanut anaphylaxis. See full profile

Texas (TX), USA

Expert in Clinical Pharmacology of Abused Drugs
Expert received his MD degree from the University of Illinois College of Medicine in 1963. He completed his rotating internship and postdoctoral research training in Neuropharmacology in 1965. After completing his training, Expert served as a ... See full profile

Maryland (MD), USA

Expert in Biostatistics Phase I, II trials, Translational research; Design, Analysis, Presentation
Md and MS in biostatistics with more than ten years of relevant professional, supervision and management experience Experience in providing support to biomedical researchers regarding statistical aspects of study design Expert in statistical ... See full profile

ON, Canada

Expert in Cardiovascular Disease, Hypertension, Arrhythmiad, Congestive Heart Failure, Internal Med, Lipids
Expert is an expert in solo cardiology and internal medicine. He has his own practice with 25 years experience in clinical, pharmacologic, medical legal consulting. Ten years experience in medical clinical trials. He is an active expert for ... See full profile

California (CA), USA

Expert in Medical Device, Diagnostic, and Pharmaceutical Clinical Trial Design and Strategy
Expert has over 25 years experience in commercializing medical products. Her experience includes management at Abbott Labs in clinical research and regulatory affairs and as a CEO of a venture capital backed medical diagnotic company. See full profile

Colorado (CO), USA

Expert in Epidemiology, Pediatrics, Infectious Diseases, HIV/AIDS, Immunology, Public Health
In her various positions at the Centers for Disease Control and Prevention, Expert has dealt with the ethical issues surrounding policy decisions involved in hemophilia-AIDS, transfusion-associated AIDS, AIDS in developing countries, AIDS ... See full profile

Oregon (OR), USA

Expert in Manufacturing Automation, Statistical Process Control
Expert has more than thirty years of experience in the analysis of process and manufacturing data aimed at improving product quality and manufacturing process yield. While at DuPont he developed a technology to uncover latent ... See full profile

Delaware (DE), USA

Expert in Transplant and Cell Therapy for Diabetes
Expert has been specialized in clinical diabetes since 1987.Initally, he was involved in metabolic studies dealing with insulin action and secretion and factors of insulin resistance. Later on, he was involved in many investigator driven studies aiming ... See full profile

Czech Republic

Expert in Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of ... See full profile

Pennsylvania (PA), USA

Expert in Internal Medicine, Hospital Medicine, Utilization Review, CMS Compliance, Faculty, Telemedicine
Expert is board-certified in Internal Medicine by the American Board of Internal Medicine. He has been practicing as a hospitalist (inpatient internal medicine) since finishing his residency training in 2007. He has worked in major, tertiary-care, ... See full profile

Florida (FL), USA

Expert in Pharmaceutical/Biotech Clinical Trials, Regulatory, R&D, Mergers & Acquisitions, Trends, Outsourcing
Expert is Director of Regulatory Affairs and Clinical Trials managing $3.6 billion at at a pharmaceutical company in New York, NY. His expertise is in managing and deploying outsource/insource teams worldwide for multiple clinical trials and ... See full profile

Michigan (MI), USA

Expert in Family Medicine, Chronic Pain, Hypnosis, General Nutrition, and Diagnostic Laboratory Procedures
Expert completed a residency in Family Medicine at First Colonial Family Practice, a part of Medical College of Virginia, in 1986, became Board Certified later that year, and became a Fellow of the Academy of Family Physicians shortly thereafter. See full profile

Virginia (VA), USA

Expert in Family Medicine, Alleged Medical Negligence, Healthcare Systems
Expert, MBChB DGM DFSRH DRCOG FRCGP MEWI, is a full time GP partner in an NHS General Practice with a 10,000 patient population, in Guildford, Surrey, UK. Expert is accredited with the Expert Witness Institute, the UK Register of Expert ... See full profile

Surrey, United Kingdom

Expert in Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials
Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of pharmaceuticals. Trained in medicinal chemistry, Expert undertook clinical pharmacology research in a ... See full profile

Victoria, Australia

Expert in Plastic and Reconctructive Surgery, Lymphedema, Medical Device Design, some Stem Cells technology
Expert has been a practicing plastic and reconstructive surgeon for 15 years. He has been the Medical Director of a Division of Plastic Surgery as well as a current Medical Director of a state certified out patient surgery center. See full profile

Arizona (AZ), USA

Expert in Medical Device Technology, Clinical Research & Business Development
Expert has decades experience in Multi-modality medical imaging: digital x-ray, ultrasound, IVUS, MRI, intra-operative MRI, multi-slice and cone beam computed tomography, hybrid PET/CT and SPECT/CT, optical coherence tomography (OCT), endo-confocal ... See full profile


Expert in Clinical Development
Expert is a Clinical Development executive with over 18 years of expertise and experience in the pharmaceutical industry. Proven track record of successfully managing large budgets with multiple programs and taking drugs from Phase I to Health ... See full profile


Expert in Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new ... See full profile

Florida (FL), USA

Expert in Physiology, Neuroscience, Epilepsy, Neurophysiology, Seizure, EEG, Neurology, Evoked Potentials, EEG
Expert, MD, is the director of Clinical Neurophysiology and the Comprehensive Epilepsy Center at a major regional hospital. He has clinical expertise in epilepsy, electroencephalography, clinical neurophysiology, and general neurology. See full profile

New York (NY), USA

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