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

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