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Globyz Clinical uses a standing Scientific/Expert Advisory Committee which consists of independent experts from the industry to effectively mitigate the risks and challenges on our client’s ongoing clinical trials. This committee provides on-going medical/technical/scientific advice, recommendations and strategic solutions on regulatory issues for drugs and medical devices in specific therapeutic areas.
Barry Poole is an international pharmaceutical consultant with noteworthy experience of 45+ years in regulatory affairs, clinical trials from start-up to close-out, product development Quality Assurance, licensing and Technology transfer, and management and specialized for GCP, GLP, ANDA, FDA, GMP, SOPs and Strategy.
He was a Manager of Medical Information and Regulatory Affairs at Squibb Canada prior to becoming a pharmaceutical consultant. Barry is skilled for the preparation, planning, coordination and execution of both early and late phase clinical trials for analgesic, cardiovascular, dermatological, oncological, ophthalmological and CNS medications.
He has significant expertise in setting up GCP operations for the CROs and pharmaceutical companies and quality management system of intraocular lenses, wound dressings and orthopedic implants, and in the planning, management and monitoring of preclinical toxicological studies for implantable devices. Additionally, he contributed for preparation of Site Reference Files, conduction of federal/regulatory inspections and perform audits of clinical trials for drug and medical device, CROs, sites and companies.
Richard Hamer bears extensive knowledge and experience over 50 years in defining regulatory strategy and clinical development, including protocol design, site ID and qualification, investigator meetings, IRB/regulatory documents, site initiation, monitoring and close-out, and drug accountability ranging from Phase I studies to Phase IV studies with extended, multi-national registration studies, for array of
investigational products.
He is the Principal Consultant at “RICHARD HAMER ASSOCIATES, LLC” and International Regulatory Affairs, Clinical, and Quality.