Questions & Answers

A Preclinical Contract Research Organization (CRO) is a specialized partner for biotech and pharmaceutical companies. They conduct the essential safety and efficacy studies required before a new drug can be tested on humans.

• In Vitro Studies: Testing the drug on cell cultures to observe molecular reactions.

• In Vivo Studies: Using animal models to evaluate how a drug is absorbed, metabolized, and excreted (Pharmacokinetics).

• Safety Pharmacology: Assessing the drug's impact on vital organ systems (heart, lungs, brain) to identify potential toxicities.

• Regulatory Support: Compiling data for Investigational New Drug (IND) applications for agencies like the FDA.