The i3 helped in the design of the studies and advised on the synthesis and labeling strategies for positron emission tomography (PET) imaging agents used to evaluate the drug.
The i3 identified an external regulatory consultant to work with Dr. Hooker to review the initial application submission and respond to the FDA’s questions.
The i3 met with the company’s senior team to understand their needs and provide guidance on how imaging could be incorporated into their development process.
The i3 provided a document management solution to Dr. Hooker’s team, providing templates for reports that incorporated auditable version control and stored the documents in a centralized server.
The i3 brought in a regulatory consultant to advise Peter on writing, document handling, quality assurance, and submission
The i3 team provided a detailed analysis of the project and identified key studies and improvements needed for human translation of the probe.