Mr. Donald originally acquired a BSc (Hons) in Molecular Biology and Biochemistry from Durham University, UK in 1987. Later he obtained a Masters in the Legal Aspects of Medical Practice (LLM) from Cardiff University, UK. An honorary lecturer at Liverpool John Moore’s University, UK, Mr. Donald is also an Honorary Fellow of the Institute of Clinical Research. After approximately 30 years in the pharmaceutical clinical research arena, he has moved to Florida where he has directed his own clinical research consultancy for the past 10 years.
Mr. Donald’s experience stretches over all elements of clinical research progressing from CRA to Head of Clinical Research for an International Organization, International Consultancy and, most recently, as a Project Director within Worldwide Clinical Trials focusing on CNS Disorders. He has experience in Phases I through IV studies in gastro-enterology, neurology (Parkinson’s Disease, Levodopa-Induced Dyskinesia, Dystonia, Schizophrenia, Neuropathic Pain and Alzheimer’s Disease), oncology, dermatology and respiratory medicine. He is proficient in project management software tools and the majority of Electronic Data Capture systems and trial master files.
Mr. Donald is passionate about Clinical Project Management and the transferable skills that this offers across therapeutic borders. An expert in GCP, informed consent and the legal aspects of Clinical Research, he has demonstrated proficiency in delivering high quality clinical trials (and documentation) acceptable to all regulatory agencies on time and within budget. Experience within the last 5 years in adaptive study designs and risk based monitoring strategies has ensured that he has been able to support the most cost-effective approach to study delivery.
Married with no children (who are far too expensive), Mr. Donald enjoys reading biographies, cooking, falling out of perfectly operating aircraft and other activities deleterious to his health.