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clinical trial documents generation


development process


Good Clinical Practice


Drug Information Association


clinical trial design


clinical research management


clinical protocol


clinical database development


documentation process


clinical trial


Clinical Trial Documents Generation Experts

The following experts are available as clinical trial documents generation consultants and clinical trial documents generation expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Clinical Trial Documents Generation - The development of documents used in a clinical trial. Clinical trial documents generation may include developing such documents as protocols, informed consent forms, case report forms, and data forms.

Synonyms:  clinical trial documents development

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Clinical Trial Documents Generation Experts
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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 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 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 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 Pharmaceutical Development, cGMP, Formulation, Analytical Development, Poorly Soluble compounds
Expert is an expert in pharmaceutical development. He has 20+ years experience solving commercially relevant problems in the pharmaceutical industry. He has extensive experience managing multi-disciplinary drug delivery projects from inception to completion, ... See full profile

Oregon (OR), USA

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 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



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