The Drug Development Unit is organized to provide comprehensive clinical research services to the faculty in the School of Medicine and pharmaceutical sponsors. Our primary expertise is in translational research, Phase I, and Phase II clinical studies, but includes all clinical phases of drug development.

Established in 1983, the DDU has conducted well over 150 trials and has worked with over 30 sponsors, including commercial and federal entities. We have an established record of productive collaborations with numerous Departments within the School of Medicine. Investigators may select from a range of support services, as needed, including:

	Development of clinical research protocols from an initial concept
	Preparation of IRB and GCRC submissions
	Clinical study implementation by ACRP-certified research nurses
	Laboratory sample processing, storage, and shipment
	Drug assay development and analysis in various fluids and tissues
	In vitro simulation of in vivo pharmacokinetic processes
	On-site quality assurance by faculty certified in Good Clinical Practice and Good Laboratory Practice procedures
	Pharmacokinetic and pharmacodynamic data analysis
	Manuscript preparation