Rho selected by HHS for clinical studies network

CRO Rho’s Federal Systems Division has been selected by the U.S. Department of Health and Human Services (HHS) to be part of a network of five CROs that will design and conduct clinical studies needed to develop medical countermeasures—drugs, vaccines and diagnostic tests that help protect public health against bioterrorism, pandemic influenza and other health emergencies.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will manage the new clinical studies network, providing a full range of services required to plan, perform, monitor and interpret clinical studies. As part of the network, Rho will support targeted clinical studies relevant to BARDA's vision to create a nation with the capability to respond quickly and effectively to deliberate, natural and emerging threats by providing a range of clinical study services that can be used by BARDA and its development partners.

The Clinical Studies Network will address both emergency and non-emergency scenarios and will encompass the following services:

Clinical Study Services: Projects will require full-service capabilities to execute clinical trials evaluating Chemical, Biological, Radiological, Nuclear (CBRN), Pandemic Influenza (PI) and/or Emerging Infectious Disease (EID) medical countermeasures. These studies may be phase I, II, III or IV or combinations of these phases.

Clinical Trial Response Readiness: Projects will address preparedness and response activities in advance of a public health emergency and may require the development and implementation of a detailed plan to permit the initiation of a clinical study within a predefined timeframe. Studies may include healthy adults, pediatric, elderly and other populations with special medical requirements.

This project is funded with federal funds from the HHS, ASPR, BARDA. The award includes a minimum guarantee of $400,000 over the initial two years and may be extended for up to a total of five years and a maximum of $100 million.