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Contract Research Organization (CRO)

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By: DAVID SAVASTANO

Contributing Editor, Coatings World and Ink World, Coatings World and Ink World Magazine

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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