October 23, 2014 2:21 PM ET

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Company Overview of Duke Clinical Research Institute

Company Overview

Duke Clinical Research Institute operates as an academic research organization in the United States and internationally. The company focuses on conducting clinical trials, managing patient registries, and performing landmark outcomes research. It offers services in the areas of advanced biomarkers, biostatistics, cardiovascular imaging, clinical events classification and review, clinical hotline or helpline, data management, discovery genomics, medical communications, project leadership, regulatory services and medical writing, safety surveillance, site management and clinical monitoring, site start-up, clinical monitoring, comparative effectiveness and outcomes studies, education/training, ...

2400 Pratt Street

North Pavilion

Durham, NC 27705

United States

Founded in 1969

Phone:

919-668-8700

Fax:

919-668-7139

Key Executives for Duke Clinical Research Institute

Chief Financial Officer
Co-Chief of Pediatric Cardiology Division and Director of Pediatrics Research
Chief of Quantitative Sciences Division and Associate Director
Chief Human Resources Officer
Director of Business Development and Contracts Management
Compensation as of Fiscal Year 2014.

Duke Clinical Research Institute Key Developments

Boehringer Ingelheim Pharmaceuticals, Inc. and Duke Clinical Research Institute Forms Collaborative Partnership to Study the Natural History of Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim Pharmaceuticals, Inc. and Duke Clinical Research Institute (DCRI) have formed a unique collaborative relationship to uncover insights into idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. As part of the partnership, Boehringer Ingelheim and Duke Clinical Research Institute will initiate a prospective, multi-center IPF registry in the United States, as well as establish a biomarker bank to identify potential blood or genetic markers of the disease that correlate with patient outcomes. The first project will be the development of the Idiopathic Pulmonary Fibrosis Outcomes Registry (IPF-PRO). This prospective, observational study is designed to provide a better understanding of the natural progression of IPF and treatment approaches for people with the condition and will launch shortly. Research indicates that IPF may affect as many as 132,000 people in the United States and the patient population may be increasing. Most patients with IPF die from the disease within three to five years of diagnosis.

Oxygen Biotherapeutics Selects Duke Clinical Research Institute to Conduct Phase 3 Trial of Levosimendan

Oxygen Biotherapeutics Inc. announced that it has selected Duke University's Duke Clinical Research Institute, (DCRI) to conduct the Phase 3 trial of the company's newly acquired compound, levosimendan. The DCRI will serve as the coordinating center and Drs. John H. Alexander and Rajendra Mehta as lead investigators for the Phase 3 trial. Levosimendan is a calcium sensitizer developed for intravenous use in hospitalized patients with acutely decompensated heart failure. The treatment is currently approved in more than 50 countries for this indication. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. Oxygen Biotherapeutics recently acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland. According to the scientific literature, LCOS occurs in 5-10% of cardiac surgery patients, and is associated with a 10 -- 15 fold increase in mortality. There is no drug currently approved for the prevention or treatment of LCOS. The Phase 3 clinical trial will study if levosimendan administered before and during surgery will reduce the incidence of LCOS and associated morbidity and mortality. There is substantial scientific evidence for the use of levosimendan in cardiovascular surgery, with over 25 published articles in peer reviewed journals and evidence of mortality reduction in some cardiac surgery trials of more than 50%. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass graphs (CABG) and/or mitral valve surgery who are at risk for developing LCOS. The trial will be a double blind, randomized, placebo controlled study seeking to enroll 760 patients. It is expected that enrollment will begin in the third quarter of 2014, and will take approximately 18 months to complete.

Oxygen Biotherapeutics, Inc. Selects Duke Clinical Research Institute to Conduct Phase 3 Trial of Levosimendan

Oxygen Biotherapeutics, Inc. announced that it has selected Duke University's Duke Clinical Research Institute, (DCRI) to conduct the Phase 3 trial of the Company's newly acquired compound, levosimendan. The DCRI will serve as the coordinating center and Drs. John H. Alexander and Rajendra Mehta as lead investigators for the Phase 3 trial. Levosimendan is a calcium sensitizer developed for intravenous use in hospitalized patients with acutely decompensated heart failure. The treatment is currently approved in more than 50 countries for this indication. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass graphs (CABG) and/or mitral valve surgery who are at risk for developing LCOS. The trial will be a double blind, randomized, placebo controlled study seeking to enroll 760 patients. It is expected that enrollment will begin in the third quarter of 2014, and will take approximately 18 months to complete. More details on the specifics of the trial will be released shortly.

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