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Clinical Trial Design Experts

The following experts are available as clinical trial design consultants and clinical trial design expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Clinical Trial Design - The process of designing an analysis using statistical methods to evaluate the effectiveness of two or more medical treatments.

Synonyms:  clinical trial designing

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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 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 Neurotechnology, Brain-Computer Interfaces, Neurological and Neurosurgical Medical Devices
Expert, MD, PhD, is a Neurologist and Translational Neuroscientist at Expert's Consulting Firm since July 2011. He was a Neurologist and Translational Neuroscientist at the University of Pennsylvania, a position he has held from July 2010 to ... See full profile

Pennsylvania (PA), USA

Expert in Endocrinology, Human Physiology, Heart Disease, Diabetes, Obesity, and Clinical Trials
Expert is clinically trained as an Endocrinologist, and performs research in human physiology and clinical trials. The basis of his work is in moving discoveries from the concept stage into human testing, often undertaking first-in-human studies or ... See full profile


Expert in Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. See full profile

Florida (FL), USA

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 Statistics, with a special interest in Evidence Synthesis and Meta-Analysis
Expert (R) Expert has 30+ years experience as an academic medical statistician. His areas of interest and expertise include clinical trial methodology; he was a member of the UK medicines regulatory body, The Committee on Safety of Medicines. See full profile

United Kingdom

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 Biostatistics, Epidemiology, Methodology, Mental Health, Police Procedures, Drug Safety, Malpractice
As a Professor of Statistics, Epidemiology, Public Health and Psychiatry for the last 30 years he has taught, applied and consulted on all of these methods. First trained as public health physician, he did his graduate work (MS and PhD) in the Division of ... See full profile

Arizona (AZ), USA

Expert in Neuropharmacology, Aging, Brain Injury, Memory Impairments, Imaging, Neurodegenerative Disorders
Expert has worked on several projects involving Alzheimer's disease (AD). In particular, he has used genetically engineered mouse models to test ideas and answer questions related to how biological memory might be affected by AD pathophysiology. See full profile

Manitoba, Canada

Expert in Safety Determinations of Food and Cosmetic Ingredients, Usage and Approval of Ingredients, GRAS
After receiving his doctorate in Biochemistry at the Marathwada University, India, Expert received his post-doctoral training atExpert's Firmand theExpert's Consulting Firm, Jackson, MS. From there he joined the National ... See full profile

Virginia (VA), USA

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 FDA Regulations, Labeling and Compliance; Medical Devices, Medical Products Liability
Expert has over 35 years medical device industry experience actively involved in the design, development, manufacture, FDA regulation compliance, labeling, and quality control of medical devices. His expertise includes implementation of corporate ... See full profile

Minnesota (MN), USA

Expert in Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many ... See full profile

New Jersey (NJ), 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 Bioethics, Medical Ethics, Ethnography Research, Qualitative Research, Good Clinical Practice, Medic
Expert is a professional bioethicist and works seamlessly among clinicians, entrepreneurs, venders, and business owners addressing critical healthcare issues such as ethics, risk, policy, content, technology, and quality care. She provides leadership to ... See full profile

Pennsylvania (PA), USA

Expert in Healthcare Information Technology, Biomedical Device Integration, Clinical Informatics
Expert has more than 28 years experience in mathematical analysis, mathematical analysis techniques and in the use of mathematical analysis for signal processing, simulation techniques and has experience over that time span in developing both simulations ... See full profile

Maryland (MD), USA

Expert in Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet ... See full profile

Massachusetts (MA), 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 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 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 Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems ... See full profile

California (CA), USA

Expert in Immunology, Vaccinology, Infectious Diseases, Recombinant Proteins
Expert has been involved in numerous animal studies examining various aspects of infectious disease agents. Expert has worked with animal models of infection with the following diverse pathogens: Schistosoma mansoni, Candida albicans, Borrelia ... See full profile

Texas (TX), USA

Expert in Immunology, Immunotherapeutics, Immunoassay Development, Cancer Biology, Cancer Immunology
Expert has 15+ years experience in developing animal cancer models including carcinogenesis, xenografts, and spontaneous and experimental metastasis models. She has also served as chairman of the animal care and use committee at a major research ... See full profile

California (CA), USA

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