Mission

The Comprehensive Clinical Trials Core at Center for Vaccine Development and Global Health, C³@CVD, empowers investigators to conduct high-quality clinical research through integrated clinical trial management, regulatory oversight, and operational excellence.

Services

C³@CVD streamlines clinical research operations with an experienced clinical trial and regulatory service center. From study start-up and IRB submissions to recruitment, research coordination, monitoring support, quality management, data capture support, and closeout, our flexible services provide the expertise and operational support needed to move studies forward efficiently and compliantly. C³@CVD ensures centralized expertise and standardized processes, improved operational efficiency, and supports the conduct of high-quality clinical research. Contact us to learn more about how C³@CVD can assist in the following categories:

• Comprehensive study start-up support for regulatory and clinical operations.
• IRB submission and continuing review preparation to help maintain study compliance throughout the trial lifecycle.
• Regulatory document preparation for:
  • Initial study start-up activities.
  • Annual continuing reviews and renewals.
  • Major protocol amendments and significant consent-form changes.
  • Minor study revisions and administrative modifications.
  • Serious adverse event documentation.
  • Study closeout and final regulatory submissions.
• Experienced regulatory specialist support for customized study needs.
• Healthy participant recruitment support designed to help research teams identify and engage eligible participants.
• Research nurse and study coordinator services, including:
  • Start-up activities.
  • Study procedures such as phlebotomy, ECG, VS, POC testing.
  • Annual study maintenance.
  • Day-to-day study coordination and follow-up activities.
  • Senior-level clinical research support.
• Audit and sponsor-monitoring visit assistance to help teams prepare for reviews, monitoring visits, and inspection-readiness activities.
• Data capture support to promote accurate, organized, and timely study information.
• Flexible service model with per-study, per-event, annual, amendment-based, and hourly options.
• End-to-end clinical research support from study activation through ongoing maintenance and closeout.
• Centralized expertise for investigators and sponsors, reducing administrative burden and allowing research teams to focus on study execution and participant care.
• Support for regulatory compliance and inspection readiness through organized documentation, safety reporting, IRB communication, and study oversight.
• Dedicated research space with private rooms for study visits.

Location

685 West Baltimore Street
Baltimore, MD 21201-1509 USA