Preclinical CRO
Definition: A Preclinical Contract Research Organization (CRO) is a specialized company that provides outsourced laboratory and animal testing services to pharmaceutical, biotechnology, and academic researchers during the early phases of drug development.
Role in Drug Development: The preclinical phase occurs before a drug candidate is tested in human subjects (clinical trials). The CRO's primary role is to generate data necessary to evaluate the potential safety and biological effectiveness of a new compound, which is required by regulatory agencies to approve an Investigational New Drug (IND) application.
Key Activities:
In Vitro Studies: Laboratory tests conducted outside a living organism, often using cell cultures or isolated tissues, to determine a drug's mechanism of action and initial toxicity profile.