Phase II/III Development

Phase II/III Development

The DCRI combines research expertise with an infrastructure comprising more than 200 practicing clinicians across all therapeutic areas, a robust collection of patient registries and outcomes data, and highly skilled research and operational teams  in the areas of statistics, clinical operations, data management, communications, and information technology. Because of this integration, the DCRI can offer study sponsors and investigators exhaustive scientific and operational support for all stages of clinical research, from first-in-human testing to applying for FDA-approval.

Proof-of-Concept Testing to Regulatory Application

The DCRI offers study sponsors and investigators exhaustive scientific and operational support for all stages of clinical research, from first-in-human testing to applying for FDA-approval.

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Data-driven Approaches to Clinical Research

Datavant and the DCRI are working together to develop innovative approaches to clinical trial design and interpretation, leveraging the power of their combined datasets. The initial work from this partnership will focus on phase II design in cardiopulmonary research.

GEMINI ACS 1

A phase II study by DCRI researchers showed that substituting rivaroxaban for aspirin in patients with acute coronary syndromes appeared to cause no significant increase in bleeding risk.

EXSCEL

A phase IIIB/IV study of type 2 diabetes, among the largest of its kind, found that the drug exenatide could be used safely by people with a wide range of existing cardiovascular conditions.