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Expert ID: 711642 Michigan, USA

Expert in Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine

Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, peritoneal, gastrointestinal, cutaneous, reproductive, urinary, and skeletal…

Expert ID: 736327 North Carolina, USA

Expert in Clinical Nursing, Critical Care and Ambulatory Services

Expert has 38 years of nursing experience, is Master's prepared, and is Adult Critical Care Certified. She is a Certified Clinical Nurse Specialist with expertise on Ambulatory Care, Neuroscience, and Critical Care. Expert is also, Manager of a COVID-19 testing…

Expert ID: 735899 Connecticut, USA

Expert in Cognitive Neuroscientist with Experience in Basic and Clinical Research

Throughout my career I have gained experience in the design and analysis of behavioral, psychophysiological, and neuroimaging studies. I have work in both academic and clinical settings and understand the unique concerns of each situation. Additionally, I have expertise 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: 735135 Ohio, USA

Expert in soy products utilization, nutritional product formulation, probiotics and prebiotics, nutritional clinical study designs

An accomplished and global clinical and nutritional leader with over 25 years of progressive experience in the botanicals, nutritional vitamins, prebiotics/probiotics, multinational healthcare, and consumer products industry sectors. Demonstrated leadership in partnering with internal technical and cross-functional operating teams in…

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: 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,…

Expert ID: 730118 Washington, USA

Expert in Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes

Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…

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