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Center for Immunization Research

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GCP Consulting for Sponsors

CIR Training Group investigators have extensive Phase I-III clinical operations and monitoring experience in developing and managing clinical vaccine programs. We can provide to trial sponsors support in the form of protocol design, writing, and implementation, as well as review of operational effectiveness and medical and safety monitoring and evaluation. Specific services we can provide include:

Site Assessment and Development

  • Identification of potential clinical trial sites
  • Site capacity building/team building

Trial Document Development

  • Research plans and protocol designs
  • Source documents
  • Policy documents
  • CRF forms and completion instructions
  • Procedures documents
  • Support documents for auditors
  • Data management manual
  • Manuals of operations
  • Monitoring plans
  • Training plans

Operational Document Development

  • Standard operating procedures
  • Manual of operations
  • Study specific procedure manual
  • Serious adverse event management and reporting manual
  • Quality management plan

Clinical Trial Monitoring

  •  FDA, ICH, and GCP compliance