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Expert ID: 723165 Colorado, 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. Expert has raised venture money…

Expert ID: 736141 District of Columbia, USA

Expert in Clinical Therapist

Mental health expert and therapist with 15 years experience in anything from severe trauma or mental illness to extensive work in love and relationships. Previously expert witness for the state of California regarding forensic mental health. QUALIFICATIONS - Behavioral Health…

Expert ID: 736097 California, USA

Expert in Psychology, Internal Medicine/Rheumatology, Clinical Medicine, Chronic Pain Management

I am a Board-Certified Rheumatologist (additionally with Boards in Internal Medicine), and extensive experience and expertise in Immunology as well. My official title is Associate Clinical Professor of Medicine and Cedars Sinai Medical Center, and I am self-employed. Appropriately, in…

Expert ID: 733995 Canada

Expert in Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process

Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…

Expert ID: 725687 Maryland, USA

Expert in Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology

As a board certified electrophysiologist, Expert has extensive experience implanting and evaluating pacemakers. In addition, she was responsible for regulating pacemakers while at the FDA. Several of her publications are in the area of pacemakers. She is a board certified…

Expert ID: 731813 Belgium

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…

Expert ID: 731580 Pennsylvania, USA

Expert in Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics

• Consultant for preparation for an FDA Advisory Committee regarding review of an NDA. • Design and implementation of Phase I-IV clinical studies • Consultant to many large pharmaceutical companies • Consultant to Biotechnology companies and CROs • Medical safety…

Expert ID: 731132 Canada

Expert in Endocrinology, Human Physiology, Heart Disease, Diabetes, Obesity, and Clinical Trials

Expert. 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 early stage…

Expert ID: 730734 Florida, USA

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. Designing preclinical, clinical and bioequivalence studies. 2. Filing…

Expert ID: 730696 Italy

Expert in Clinical Development, 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", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…

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