close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished

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.
Biomedical Scientist Design Assurance Biotechnology New Product Development Engineer Validation Scientist R & D Technician Quality Engineer Senior Regulatory Affairs Officer Product Development Technologist Biostatistician Regulatory Affairs Specialist Process Technician Project Engineer Process Development Engineer Biotechnology Specialist QE Manufacturing Engineer Mechanical Engineer Clinical Trials Advisor Technical Support Academic Senior Operations Engineer Technical Specialist Senior Research and Development Engineer Engineering Manager Regulatory Affairs Director Project Manager Senior Research and Development Scientist Quality Systems Lead Sligo Dublin West Medical Device Engineering Regulatory Affairs Clinical Research Regulatory Affairs Manager Clinical Research EHS Engineer Junior Product Specialist Leinster Senior Project Manager North Leinster Senior Scientist Electrical Engineer Applications Engineer Validation Engineer Project Development Engineer Manufacturing and Technology Manager Sales Engineer Senior Manufacturing Engineer Principal Engineer Regulatory Affairs Officer Electronic Engineer Quality Systems Specialist QA Manager Clare Life Science Clinical Project Manager Design Engineer Research Engineer QA Supervisor Regulatory Affairs Healthcare Product Manager QA RA Engineer Research and Development Senior Project Engineer Technical Project Manager NPD Technologist Quality Manager R and D Manager Roscommon Research and Development Engineer Project Lead R and D Biochemist Connected Health Limerick Lead Quality Engineer Limerick City Cork Dublin North Life Science Research Scientist Product Development Engineer Research and Development Technician Snr Validation Engineer Kildare Validation Coordinator Quality Control Supervisor Technical Support Specialist Academic Snr R and D Engineer Pharmaceutical Athlone Scientific Principal Scientist Galway City QA Validation Specialist Dublin South QA Specialist Consultant (Medical) Meath Dublin City Centre Engineering Manufacturing Engineer Medical Affairs Regulatory Affairs Research Fellow Senior Quality Engineer Clinical Research Nurse Quality Specialist Supplier Quality Engineer BD Manager Clinical Research Associate Galway Research and Development Scientist Dublin Quality Systems Engineer Laois Principal Research Scientist Process Engineer Quality Control Manager Dublin Greater Validation Specialist R and D Director Regulatory Affairs Consultant Product Specialist Biopharmaceutical Hardware Implementation Engineer QA Engineer Quality Assurance Regulatory Affairs Executive QA Executive Biomedical Engineer