- Created: 10-11-20
Description: If you are interested in CRO preclinical testing, there are two basic options for obtaining clinical tests: direct-to-consumer (dTC) testing or preclinical testing through a facility like Celis. DTC testing, which usually occurs at the manufacturer's facilities, is more expensive than preclinical testing, but offers the convenience of having a new drug immediately available for use in clinical trials. It is important, however, to remember that the drug being tested must be approved by the FDA in order to be approved in the dTC format. Once your company is ready to enter the CRO testing market, you will need to contact the regulatory agencies that regulate the market. There are two primary agencies that regulate this type of testing, the Biologics License Application Monitoring System (BLAM) and the Biologics License Application Approval System (BLAS). Both organizations require companies to conduct both preclinical and post-market tests on their drugs and to submit them to the FDA in order to receive approval. There is no limit on the number of tests that a CRO test can include, and there are no restrictions placed on what types of subjects may be used for testing. The main restriction that does exist is that the subjects in the clinical trial should be healthy adults over 18 years of age, with no history of drug toxicity or medical conditions that could interfere with the drug's effects. In addition to providing information about the safety and effectiveness of a drug, a clinical trial can also provide valuable insight into how the drug works in the body. Because of the complicated nature of the human brain and the many different areas that it controls, a good CRO test will often include functional imaging, blood analyses, neurophysiological testing and clinical trial pharmacology. In a clinical trial, the goal is to provide unbiased information about the effectiveness of a drug in terms of a specific condition, so that scientists can make informed decisions about whether or not to introduce the drug in a future clinical trial. The information provided can also help to inform whether or not to make further clinical trials for the drug. The CRO testing industry is a fast growing and exciting area, and CROs are quickly discovering that the clinical drug industry is hungry for clinical data from both the pharmaceutical and biotechnology sectors. It is a wonderful time for small, independent CROs, because they are often able to provide highly personalized treatments to patients who are struggling with life-threatening diseases, without the burden of multiple large pharmaceutical companies.
Publish Date: 10-11-20