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School of Medicine
Drug Development Unit
The Drug Development Unit (DDU) provides clinical research services and support to the faculty of the School of Medicine and to pharmaceutical sponsors. A wide range of services are available, from protocol design and clinical and laboratory support and data analysis, to administrative services including clinical trial agreement negotiation as well as IND and project management.
The Unit provides comprehensive clinical research support services with experienced faculty and staff that include:
- Faculty with decades-long experience in the design and conduct of clinical research, primarily phase I and phase II
- Staff engaged in training and educating clinical research coordinators locally, nationally and internationally
- An experienced research team with wide collaborations among the medical specialties at the Johns Hopkins School of Medicine
- A history of diverse partnerships including numerous pharmaceutical sponsors, fellow academic medical centers, the National Institutes of Health, the Centers for Disease Control, the Food and Drug Administration, and private foundations
- All studies are coordinated by clinical research nurses or individuals with masters-level degrees
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 over 200 trials and clinical studies 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.
The DDU integrates services with the Clinical Pharmacology Analytical Lab (CPAL) to provide a complete range of services for the support of clinical studies of drugs. Investigators and sponsors may select from a range of support services from development of concept proposals to manuscript preparation.