Rho

HHS/ASPR/BARDA Medical Countermeasures Clinical Studies Network (MCM CSN)

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)

Prime: Rho

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.

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)