Phase I Unit

phase 1 cover

Request CTRI Services

The CCR includes a dedicated phase I unit for pharmacokinetic, biomarker and safety studies. In phase I studies, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

The CTRI launched the phase I unit in 2014 to meet an increasing demand for first-in-human and first-in-disease studies. The unit offers clinical trial space, an investigational pharmacy, an infusion center, and a slate of services, from nursing and clinical coordination, to biostatistics and labs, to physician oversight and investigational drug compounding. It recently expanded to incorporate omics-based biomarkers in very early clinical trials, including the infrastructure to collect, process, and analyze biosamples using cutting edge omics and biomarker tools. Research subjects are identified through disease-specific registries, and the unit can perform 24-hour and weekend pharmacokinetic studies, as well as support sample acquisition and processing at all hours.

Directed by Mark Wallace, MD, the phase I unit includes a nurse administrator and project manager to enable the quick and efficient launch and management of clinical trials.

For Phase I Unit services, please click on the "Request CTRI Services" button above. You may also contact Mary Maeve Taaffe, RN, Nurse Supervisor, at (858) 822-1717, cell (858) 334-9769.