Specialized Facilities and Technologies
Duke Early Phase Clinical Research has the capability to provide services in both inpatient and outpatient settings. The Early Phase Unit has 10 hospital-graded beds to service the needs of research subjects who require specialized hospital care during the course of their study visit.
Our hospital-based beds maximize subject safety and provide on-site access to a full array of specialized procedures and technologies. The remaining beds are classified as confinement beds. These beds are designed to house subjects who do not require medical standard-of-care procedures during their study stay.
Additionally, the Early Phase Unit has six well-equipped examination rooms, two processing laboratories, and a metabolic kitchen.
Subjects have access to wireless Internet throughout the clinic and televisions in their shared rooms. If protocols permit, subjects can also access our multipurpose room, a subject reading room, laundry facility, and a large, comfortable lounge equipped with games, computers, and television.
We have immediate, around-the-clock access to an on-site, full-scale emergency response team and MD coverage. The Early Phase Unit also provides extensive security measures for your staff and subjects, including cameras, alarms, locked elevators, and Duke Security personnel on-site 24 hours a day.
We offer access to a variety of core laboratories equipped with cutting-edge technologies to better understand disease and predict drug response.
- Real-time ECG collection, monitoring, and interpretation. We use Mortara® wireless 12-lead ECG digital telemetry, allowing for easy transfer of data.
Immune system effects
- Examination of the subtle effects of medical interventions on the human immune system. This includes immunogenicity, immunocompetence, immune reconstitution, and immunotoxicity. Our partnering laboratory uses immunoassays that are robust and reproducible, highly sensitive and specific, and fully validated and standardized to support multicenter studies.
- Specialized “omics” equipment and expertise. The omics facilities we can access perform high-throughput assays and data analysis for genome sequencing, genotyping, gene expression, proteomics, and metabolomics to study the effects of medical interventions on human physiology and disease states.
- Receipt of cellular products (frozen, refrigerated, or room temperature). The Investigational Drug Services pharmacy at Duke prepares products for infusion according to suppliers’ specifications and creates appropriate infusion records.
- State-of-the-art, highly secure image-management and digital archival systems and world-class consultative services. Our accessible imaging labs offer advanced nuclear imaging, echocardiography, and spectral domain OCT scanning technologies.
- Data integration. Our informatics capabilities include extensive experience integrating phenotypic and biological marker data.