BARDA is pleased to announce the recipients of the Medical Countermeasures Clinical Studies Network (CSN) contract awards. The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the support development and acquisition of MCMs to prevent or treat the medical consequences of Chemical, Biological, Radiological, and Nuclear (CBRN) threats, Pandemic Influenza (PI), and Emerging Infectious Diseases (EID). These MCMs include vaccines, therapeutics, diagnostics, and medical devices.
BARDA established the CSN as a core service in 2012 and awarded IDIQ contracts to five (5) full service clinical Contract Research Organizations (CROs) in 2014 to form the CSN infrastructure. During the network’s five years, several important gaps in capabilities were identified. Three separate and distinct solicitations have been awarded to address the following gaps: Clinical Trial Planning & Execution (CTPE) services on a routine basis to address the requirements under regular non-emergency timelines, as well as services during emergencies when rapid timelines are crucial; a Biological Specimen and Investigational Product storage facility (BSIP); and a Statistical and Data Coordinating Center.
The network is comprised of three components that will integrate to provide BARDA partners and medical countermeasure developers with technical and regulatory assistance in the 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.
The Clinical Trials Planning and Execution component will be responsible for planning and execution of clinical studies to support medical countermeasure development and was awarded to four recipients: ICON Government & Public Health Solutions, Pharm-Olam LLC, PRA Health Sciences, Inc. and Technical Resources International, Inc. The Statistical Data Coordinating Center will serve to standardize data collection, management, and analysis across studies that use this BARDA-supported network and was awarded to Rho Federal Systems Division, Inc. The Biological Specimen and Investigational Product Storage Facility will provide a single facility for long-term storage of clinical study specimens and investigational products across BARDA-supported studies was awarded to ATCC Federal Solutions.
About ATCC:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
ATCC is a premier global biological materials and information resource and standards organization and the leading developer and supplier of authenticated cell lines and microorganisms. With a history of scientific advancements spanning nearly a century, ATCC offers an unmatched combination of being the world’s largest and most diverse collection of biological research solutions and a mission-driven, trusted partner that supports government sponsored research and development in infectious and chronic disease, and encourages scientific collaboration. ATCC products, services, and people provide the scientific community with credible biological products, advanced model systems, and custom solutions that support complex research in a variety of innovative applications resulting in incredible achievements in basic science, drug discovery, translational medicine, and public health. ATCC is a nonprofit organization with headquarters in Manassas, Virginia, and an R & D innovation center in Gaithersburg, Maryland.
About ICON Government & Public Health Solutions (ICON):
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
ICON Government & Public Health Solutions (GPHS) is ICON's federal business unit providing full service and functional research solutions. GPHS primarily supports US government biomedical research facilities, and commercial clients leveraging US government funding for product development.
Our clinical development expertise extends across basic and applied research, vaccines development and testing, response to bio-threats, TBI, PTSD, Pain, trauma medicine, oncology and infectious and neglected tropical diseases.
ICON Government and Public Health Solutions have over 25 years’ experience of contracting with US Federal agencies.
ICON operates from 94 locations in 40 countries. Further information is available at www.ICONplc.com/GPHS
About Pharm-Olam LLC:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Pharm-Olam is a global clinical research organization (CRO) focused on delivering clinical trial service solutions to pharmaceutical, biotechnology, government, and public health organizations around the world. Founded in 1994, with operations in 60+ countries, Pharm-Olam's mission is to create a healthier world through agile, innovative, and customized clinical trial solutions for Phase I-IV research. Pharm-Olam has extensive experience in medical countermeasures (MCM) clinical research and is focused on infectious disease, oncology, autoimmune, and rare disease clinical trial delivery. The CRO has focused efforts on supporting US government clinical research and has been a part of over $800M in government-funded trials with several agencies, including NIH, DOD, BARDA, and CDC. Learn more at www.pharm-olam.com.
About Pharmaceutical Research Associates, Inc (PRA):
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.
About Rho Federal Systems Division, Inc.:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Rho Federal Systems Division, Inc. is a wholly owned subsidiary of Rho, Inc., a full-service CRO providing a full range of drug development services from program strategy through clinical trials and marketing applications. Over the past 25 years, Rho has supported more than $500 million of federally funded research across multiple federal agencies and multiple therapeutic areas. In addition to serving as multiple statistical and data coordinating centers (SDCCs), Rho provides full-service support for Phase 1-4 clinical trials and observational studies and provides clinical research and regulatory affairs support services and consulting. To learn more about Rho, please visit www.rhoworld.com.
About Technical Resources International, Inc, (TRI):
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Technical Resources International, Inc. (TRI) is a full-service contract research organization (CRO). TRI’s areas of expertise include clinical trials management, clinical operations, regulatory affairs, medical writing, safety & pharmacovigilance, data management & biostatistics, data analytics and visualization, bioinformatics, quality assurance, training, communications, event planning and management, and information technology. For more than 41 years, TRI has provided support to government agencies, the private sector, and non-profit organizations. Further information is available at www.tech-res.com
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