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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.