RESEARCH TRIANGLE PARK, NC / ACCESSWIRE / September 25, 2023 / The U.S. Department of Health and Human Services (HHS) has awarded a new project to Rho Federal Systems Division, Inc, a wholly owned subsidiary of Rho, to provide Statistical and Data Coordinating Center (SDCC) services for Phase 2b clinical trials evaluating the next generation of COVID-19 vaccine candidates. This is Rho’s fifth award since becoming the SDCC for the Medical Countermeasures (MCM) Clinical Studies Network in 2020.
The project is part of Project NextGen, a $5 billion initiative led by two offices within HHS – the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health – to accelerate and streamline the rapid development of vaccines and treatments through public-private collaborations.
Rho, a global, full-service contract research organization (CRO) with a proven track record of drug development success, is one of the first groups to participate in Project NextGen’s Strengthen Program. This specific initiative supports clinical development of vaccines with the potential to expand coverage against variants and extend the duration of protection over currently available vaccines.
“COVID-19 vaccines introduced innovations that changed the way we think about vaccines. BARDA’s upcoming studies will continue the leading-edge development that began with large-scale mRNA vaccines,” said Dr. Peter Schmidt, chief scientific officer, Rho. “Our breadth of experience, coupled with our close collaboration with BARDA as part of its Medical Countermeasures Clinical Studies Network, puts us in an ideal position to evaluate the efficacy of new vaccines that will reduce infection and transmission.”
While existing vaccines against COVID-19 are still highly effective at preventing serious illness and death, they are less capable of reducing infection and transmission over time. Similarly, previously authorized monoclonal antibody therapeutics critical to treating individuals and protecting some of our most vulnerable populations are not effective against currently circulating strains in the U.S.
Under the new agreement, Rho will provide protocol development services, full-scope data management and statistical support, regulatory services, safety and pharmacovigilance, DSMB (Data and Safety Monitoring Board) support, and project management.
These clinical trials for new vaccine candidates targeting longer-lasting protection against future variants are expected to begin enrolling subjects in September 2024.
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. 75A50120D00015.
Rho is a global, privately held contract research organization (CRO) headquartered in Research Triangle Park, a biotech hub in North Carolina, US. Rho provides a full range of drug development services, from program strategy through to clinical trials and marketing applications. For more than 39 years, Rho has been a trusted partner to some of the most innovative pharmaceutical, biotechnology and medical device companies as well as academic and government organizations. Dedicated to service excellence and cross-functional collaboration, Rho’s therapeutic expertise, employee focus and commitment to strong site relationships change what it means to work with a CRO – accelerating time to market, maximizing ROI, and delivering consistent, smarter and more efficient programs. Experience Rho by following the company on Facebook, LinkedIn, Twitter, and Instagram.
Julie Colman (on behalf of Rho)
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