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Good Clinical Practice Experts| The following experts are available as Good Clinical Practice consultants and Good Clinical Practice expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Good Clinical Practice -
According to the FDA, Good Clinical Practice is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. It applies to devices, drugs, and biologics. It is one of the three sets of regulations that go into GXP: Good Laboratory Practices, Good Manufacturing Practices, and Good Clinical Practices. Synonyms: GCP |
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Expert Quote | | |  | | Expert in Family Medicine, Geriatrics and Agricultural Medicine
Expert is board certified by the American Board of Family Practice with a subspecialty in Geriatrics and is family physician with 34 years experience as a faculty member in a medical school. He has a fellowship in geriatric medicine from Johns ... See full profile | | South Carolina (SC), USA  | | | |  | | Expert in Pharmaceutical Regulatory Affairs and Quality Compliance
Expert provides regulatory consulting services to the pharmaceutical, biologics, medical device and food industry to assure compliance with U.S. Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), ... See full profile | | Indiana (IN), USA | | | |  | | Expert in Medical consulting, Medical Writing, Effective Ad Strategies Targeting Physicians
Expert is a physician and medical writer with 15 years of experience. He has written three research protocols and completed the studies while at NYU Medical Center. While in clinical practice he published 8 articles in medical journals and ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Bioethics, Medical Ethics, Ethnography Research, Qualitative Research, Good Clinical Practice, Medic
Expert is a professional bioethicist and works seamlessly among medical professionals, clinicians and community organizations addressing critical healthcare issues such as ethics, risk, policy and quality care. Conducting clinical bioethics ... See full profile | | Pennsylvania (PA), USA | | | |  | | Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
I am a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; I acquired more than 21 years' experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects ... See full profile | | Québec, Canada | | | |  | | 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 Medical Device Technology, Molecular Biology, Virology, Infectious Diseases, Tissue Engineering
Expert is a Clinical Trials manager in the National Health Service, UK; where she is involved in Stroke trials. She has had significant experience in the area of Tissue engineering and Stem cell biology for the last 5 1/2 years where she worked as a ... See full profile | | United Kingdom | | | | | | 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 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 Development
Expert is a Clinical Development executive with over 13 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 | | Switzerland | | | |  | | Expert in Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles to the ... See full profile | | Germany | | | |  | | Expert in Healthcare Industry, Telemedicine, Healthcare Market Research, Best Clinical Practices, Urgent Care.
Expert has over 15 years of experience in clinical medicine. He has served as Medical Director and/or Department Chairman for 7 Emergency Departments nationally, focused on implementation of Clinical Best Practices. He has served as National ... See full profile | | Texas (TX), 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 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 Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile | | California (CA), USA | | | |  | | 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. He has worked in major, tertiary-care, referral ... 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
As a family physician for over 12 years, Expert has worked in private/group practice, urgent/walk-in care, and occupational medicine, and has a good field of knowledge in each of these areas. She also has an interest in case review and documentation, ... See full profile | | Texas (TX), 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 Family Medicine, Graduate Medical Education
Expert has been practicing and teaching family medicine since 1981. She has been Program Director of a family medicine residency training program since 1994. She completed an MPH in Health Systems Organization and an MBA and has 20 years of ... See full profile | | California (CA), USA | | | |  | | Expert in Physician Assistant Practice, Medical Malpractice & Standard of Care, All Clinical Specialties
Expert is a Physician Assistant expert, records reviewer and witness for all cases involving physician assistants; Eighteen years clinical practice experience in family medicine, emergency medicine, occupational health, urgent care, internal ... See full profile | | Wisconsin (WI), USA | | | |  | | Expert in Addiction in Pain Patients, Clinical Research, Analgesia, Neuroscience, Nursing, Sedatives, Morphine
Expert has expert knowledge of the different classes of abused drugs (including alcohol), both their unique clinical pharmacology and their shared effects on neural reward and memory systems. Specifically, she can speak on the neurochemistry and ... See full profile | | California (CA), USA | | |  | | >> Next 25 Experts
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