Regulatory Team

The Regulatory Team has the primary responsibility at the start and throughout the trial for the following activities:

• Investigational Review Board (IRB) tasks
• Contract duties
• Regulatory and Food and Drug Administration (FDA) required tasks

This is the “starter” group of all new projects, and their job is to complete all requirements for study initiation within four weeks. For a sponsor, this means that in four weeks they will have:

• All FDA documents complete and in their hands
• A Contracted Research Organization (CRO)
• A fully executed contract
• IRB approval of the protocol, consent and any special project tools

The focus of this team is accuracy and efficiency, and the result is seen in their track record. In more than 50 percent of all trials, the Lindner Research Center is the first site to be initiated.