Glossary

Contract Research Organization (CRO)

02.27.12

A company involved in performing non-clinical or clinical research on a contract basis for a pharmaceutical or Biotech company, research organization, or other health organization. For non-clinical CROs, studies or full programs are contracted by the sponsor, and may include early discovery screening tudies, Toxicology, Safety Pharmacology , Genetic Toxicology, Bioanalytical assays, Drug Metabolism and Pharmacokinetic studies. For clincal CROs, the outsourced work may include enrolling patients, writing the Protocol , conducting and monitoring the trial, running analytical lab tests or bioanalytical assays, performing statistical analysis, and writing the report and regulatory submission documents.

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