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Clinical Services Support Division

Mission

Provides clinical and nonclinical support services for FDA-regulated medical products throughout the DoD acquisition spectrum, from candidate optimization to product approval:

  • Investigational New Drug (IND) product manufacturing, testing and accountability
  • Clinical study monitoring and data management
  • Nonclinical study design and GLP compliance review
  • Biostatistical support, including study design and data analysis
  • Adverse event reporting and safety surveillance
  • Study site visits for cGMP, GLP and GCP compliance
CSSD organization chart

Product Safety Surveillance

  • Adverse Events Review & Reporting to FDA
  • Product safety monitoring
  • Adverse Events Coding (MedDRA) for safety analysis

Clinical Operations & Data Management

  • Advise on clinical protocol development
  • Provide clinical site selection and development support, including SOP development
  • Provide clinical trial monitoring services
  • Ensure study volunteer rights are protected
  • Provide clinical database design and implementation; Design Case Report Forms
  • Provide clinical data management support
  • Provide clinical site training

Product Technical Operations

  • Conduct GMP and GLP facility audits
  • Lot release and stability protocol development & review
  • Support IND product manufacturing, testing, shipping, accountability
  • Advise on GLP animal study design and execution
  • Advise on non-clinical study requirements
  • Advise on assay validation requirements
  • Advise on equipment validation

Biostatistics

  • Advise on Clinical Development Strategies
  • Advise on appropriate protocol design
  • Provide data analysis
  • Provide oversight of CRO statistical support
Last Modified Date: 19-Nov-2010