Global Clinical Research
Global Clinical Research (GCR) investigates new molecular entities as well as marketed products for initial and new indications in a range of therapeutic areas. This is accomplished through an understanding of the scientific foundation of new molecular entities and the disease that the compound could potentially treat. GCR works collaboratively to create protocols for testing hypotheses and determining dose, schedule and treatment effects in comparison to standard of care and/or placebo.
This group is also responsible for the summarization, interpretation and reporting of clinical trial data. These trials vary in scope, from investigational studies in human trials of 10 to 20 subjects at a single site to global pivotal registration trials in several thousand patients conducted at hundreds of sites. GCR also prepares registration dossiers seeking marketing approval for investigational products. Finally, GCR collaborates with Global Pharmacovigilance on interpretation of safety data and production of safety summaries for marketed products.