Sponsor: Department of Health and Human Services (HHS) / Office of the Assistant Secretary for Preparedness and Response (ASPR) /Biomedical Advanced Research and Development Authority (BARDA)

Project Information: Rho is 1 of 5 contract research organizations in the BARDA MCM CSN ID/IQ multiple award task order contract (MATOC) pool that competes for full-service task orders to 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.

Projects Awarded to Date:

• Phase 2 Panblok® H7 Influenza Vaccine at Three Dose Levels Adjuvanted with AS03 or MF59 Vaccine Trial
• Phase 2 Safety and Immunogenicity of Anthrax Vaccine in Individuals over 65
• Phase 1 Randomized, Three-Way Crossover Study to Assess the Bioavailability and Pharmacokinetics of a Single Dose of Atropine Administered Sublingually in Healthy Adult Volunteers

Services:

• Biostatistics and Statistical Programming
• Clinical Project Management
• Project and Site Management
• Protocol Design/Development
• Safety Monitoring/Pharmacovigilance
• Data Management and Analysis
• Manuscript and Regulatory Document Submission
• Organizational and Logistical Support, Including Meeting Coordination
• Study Website Content Development and Maintenance
• Study-Related Approvals, Including IRB Submissions
• Training and Training-Related Activities
• Biospecimen Collection Kit/Supplies Management, Tracking
• Process Documentation Development (e.g., SOPS)