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Organisational Structure Clinical Research Sector

Clinical Research, in an industrial context, refers to the clinical research and development activities of life science companies and contract research organisations. There is an ongoing sustained development of drugs and new technologies within the industry and the clinical research sector is concerned with the development and licensing of these products from early stage target identification, to lead generation, to preclinical trials and on to phase I, II and III clinical trials. The clinical research sector has a number of different departments which work together to ensure the products moves from development into commercialisation. The phases of development and launch of a drug are as follows...
  • Target Identification and Lead Generation (Chemistry / Pharmacology)
  • Preclinical Studies (Toxicology / Pharmacology)
  • Phase I Human Trials (Medical / Pharmacology)
  • Phase II Human Trials (Medical / Data Management)
  • Phase III Human Trials (Medical / Data Mgmt / Regulatory / Pharmacovigilance)
  • Launch
  • Phase IV Post-Market Surveillance (Regulatory / Pharmacovigilance)

Drug Discovery is the first stage in the clinical research process. Chemists and pharmacologists work together to identify high potential candidates for further testing.

  • Combinatorial Chemistry
  • Pharmacology

Pre-Clinical Studies involves testing high potential candidate drugs for teratogenicity and toxicity

Human Clinical Trials Phase I-III

  • Phase I - Small Human Trial - Tolerance
  • Phase II - Large Scale Human Trial - Single Centre
  • Phase III - Large Scale Human Trial - Multicentre, Multi-Geography

Team Members Involved

Phase IV - Post-Market Surveillance Involves the monitoring of SAE's (Serious Adverse Events) and reporting of other side effects of launched drug by health care professionals (HCP's) in the field, managed by pharmacovigilance team.
Scientific Engineering EHS Engineer Healthcare Meath Engineering Design Engineer QA Specialist Regulatory Affairs QA Manager Lead Quality Engineer Quality Control Supervisor Quality Engineer Laois Life Science Senior Research and Development Engineer BD Executive Quality Systems Engineer Senior Research and Development Scientist Research Scientist Quality Control Manager Medical Affairs QE Manufacturing Engineer Research Fellow QA RA Engineer Process Development Engineer Dublin West Research and Development Validation Scientist Pharmaceutical Supplier Quality Engineer Technical Specialist Dublin City Centre Snr R and D Engineer Postdoctoral Research Fellowship Principal Scientist Dublin South Connected Health Galway QA Supervisor PhD Senior Operations Engineer Manufacturing Engineer Process Engineer Quality Systems Specialist Clinical Research Dublin Business Development Manager Scientific Sales Business Development Business Development Executive Clare Product Specialist Leinster Molecular Biologist Biotechnology Electronic Engineer Mechanical Engineer Senior Project Engineer Academic BD Manager Research and Development Technician Limerick City Microbiology Account Manager Biopharmaceutical Biomedical Engineer Kildare R and D Biochemist Project Engineer Electrical Engineer Sales Engineer NPD Technologist QA Validation Specialist QA Engineer R & D Technician Dublin Greater Galway City Product Development Technologist Validation Specialist Dublin North Laboratory Scientist Quality Assurance Project Development Engineer Senior Scientist Clinical Research Nurse Clinical Project Manager Technical Support Clinical Trials Advisor Product Development Engineer Quality Specialist Academic PhD Sales Executive Research and Development Engineer Validation Engineer Product Manager Research Engineer Medical Device Research and Development Scientist Project Lead Roscommon Principal Engineer Quality Manager R and D Manager Design Assurance Process Technician Cork Life Science Clinical Research Associate New Product Development Engineer Quality Systems Lead Principal Research Scientist Project Manager Sligo Limerick