Contract Pharma Staff11.10.20
Rho Federal Systems Division Inc. (RhoFED) has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services to manage a Statistical and Data Coordinating Center (SDCC) for BARDA’s Medical Countermeasures Clinical Studies Network. Under the contract, RhoFED will be responsible for standardizing data collection, management, and analysis across BARDA-supported network studies.
As one of five full-service clinical CROs in BARDA’s original clinical studies network, RhoFED conducted three clinical trials to support BARDA’s national health security efforts and has a fourth influenza vaccine study in development.
“We are honored to continue our work with BARDA and aid in the search for safer and more effective medical countermeasures,” said Laura Helms Reece, CEO, Rho. “Rho brings more than 25 years of storied expertise in federal research support, and we are dedicated to bringing the best of Rho’s data management and biostatistics capabilities to our new responsibility as the SDCC.”
Supporting BARDA’s Mission
The SDCC will integrate with the new Biological Specimen and Investigational Product storage facility and four Clinical Trial Planning and Execution providers in support of BARDA’s mission, in partnership with medical countermeasure developers, by providing technical and regulatory assistance in development of vaccines, therapeutics, diagnostics, and medical devices to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear threats; pandemic influenza; and emerging infectious diseases.
As the SDCC manager, RhoFED will perform clinical trial data management, data quality control, data monitoring and statistical analyses, study design, Safety Monitoring Committee or Data and Safety Monitoring Board support, medical monitoring, data analysis, and reporting services. Included in RhoFED’s services is the capability of providing innovative trial design and system readiness for rapid trial start-up, which is critical to meeting the challenges of developing MCMs for emerging public health threats.
In addition, RhoFED will also provide a centralized clinical study record archive for long-term storage and, as needed, access to data mining capabilities via health care utilization databases through a strategic partnership.
RhoFED’s work as the SDCC will be funded with federal funds under BARDA Contract No. 75A50120D00015.
As one of five full-service clinical CROs in BARDA’s original clinical studies network, RhoFED conducted three clinical trials to support BARDA’s national health security efforts and has a fourth influenza vaccine study in development.
“We are honored to continue our work with BARDA and aid in the search for safer and more effective medical countermeasures,” said Laura Helms Reece, CEO, Rho. “Rho brings more than 25 years of storied expertise in federal research support, and we are dedicated to bringing the best of Rho’s data management and biostatistics capabilities to our new responsibility as the SDCC.”
Supporting BARDA’s Mission
The SDCC will integrate with the new Biological Specimen and Investigational Product storage facility and four Clinical Trial Planning and Execution providers in support of BARDA’s mission, in partnership with medical countermeasure developers, by providing technical and regulatory assistance in development of vaccines, therapeutics, diagnostics, and medical devices to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear threats; pandemic influenza; and emerging infectious diseases.
As the SDCC manager, RhoFED will perform clinical trial data management, data quality control, data monitoring and statistical analyses, study design, Safety Monitoring Committee or Data and Safety Monitoring Board support, medical monitoring, data analysis, and reporting services. Included in RhoFED’s services is the capability of providing innovative trial design and system readiness for rapid trial start-up, which is critical to meeting the challenges of developing MCMs for emerging public health threats.
In addition, RhoFED will also provide a centralized clinical study record archive for long-term storage and, as needed, access to data mining capabilities via health care utilization databases through a strategic partnership.
RhoFED’s work as the SDCC will be funded with federal funds under BARDA Contract No. 75A50120D00015.
