GCO is a service organization for Johnson & Johnson Pharma which performs clinical studies for all pharmaceutical products under development by one of the Johnson & Johnson Pharma Companies. These can be Centocor products or medicines in development by other companies within Johnson & Johnson. The clinical studies are often global studies, and the data generated in these studies are collected to become part of the marketing authorization application dossier which is prepared and submitted by Global Regulatory Affairs. GCO is organized, just as GRA, along therapeutic areas: Immunology, Oncology, Infectious Diseases, Cardiovascular disease and CNS.
The Quality Monitoring & Compliance Group of GCO is global responsible for Risk Management strategies. It provides a central support to quality monitoring of clinical studies which are carried out by third parties (Contract Research Organizations).
The Operations Support Group provides support for submissions of clinical trial applications to Health Authorities and Ethics Committees, support for creation of documents such as the Patient Information Sheet. It also provides support in quality monitoring of studies which involve so called Independent Drug Monitors and studies which require close temperature control of the study drug.
Other support groups within GCO are Study Placement (responsible for do-ability research for clinical studies) and the Contracts & Grants/Insurance group, which takes care of contracts with hospitals and clinical investigators who participate in our studies as well as insurances for various parties involved in the clinical studies.
The Clinical Operations Group within Medical Affairs which carries out clinical studies with marketed products is too part of Global Clinical Operations.
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