What to Look for When Partnering with a CRO for CNS Clinical Trials
When your organization develops a drug that affects the central nervous system, early clinical development can be complex, and requires teams with extensive clinical research expertise. As a result, many organizations partner with a contract research organization that has the necessary experience to conduct their CNS trials during the early stages of the drug development process. Here are a few factors to keep in mind when your organization is searching for the right CRO partner for your CNS trials. Experience Handling Regulations Regulations for CNS drugs can be intricately detailed. You want to find a CRO with experience in adaptive trial designs often associated with CNS clinical trials and therapies, as well as bioanalysis needed for on-time regulatory submissions. The CRO team should also have experience working with Institutional Review Boards. Familiarity with IRBs means your protocol will be submission-ready while minimizing the potential for making amendments later, thus sh...