Project: Medical Countermeasures Clinical Studies Network (MCM CSN)
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 Status: Active
Project Start: April 2014
Diseases: Pandemic Influenza, Emerging Infectious Diseases
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. Rho has won 2 full-service, rapid timeline medical countermeasure vaccine trial (H7N9 influenza and anthrax) task orders under this MATOC.
See Task Order Description for PanBlok® H7 Influenza Vaccine at Three Dose Levels Adjuvanted with AS03 or MF59 Vaccine Trial (Phase 2).
See Task Order Description for BARA Securing Anthrax Immunity for the Elderly (B-SAFE) Vaccine Trial (Phase 2).
- 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)