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Welcome! Meet the Clinical Development Team

Our Mission

Helping make your clinical trial concept into a fully operational reality. 

Our Role within UNC Lineberger Comprehensive Cancer Center

  • Protocol concept development
    • Aiding in authoring of letters of intent (LOIs), including completion of budget worksheets for proposal budget development
    • Protocol/regulatory strategic guidance
  • Clinical Protocols
    • Co-authoring LCCC treatment trial clinical protocols
    • Providing guidance for the development of other LCCC sponsored clinical protocols
    • Writing protocol amendments
  • Administrative Letters
  • Model Informed Consent Form
    • Initial
    • Amendments due to clinical protocol amendments
    • Amendments due to Investigator’s Brochure updates
  • Patient Education Materials
  • Investigational New Drug (IND) applications
    • Initial applications
    • FDA requests for information
    • Serial submissions
    • Project management of maintenance serial submissions
    • Compassionate use
  • Compliant data submissions to FDA
    • IND Application Annual Report data deliverables
    • Implementing FDA supported data standards
    • Study Data Standardization Plan for electronic submissions
    • Submitting study data using the electronic Common Technical Document (eCTD) format
    • FDA compliant datasets for Investigator Brochures
  • Investigator’s Brochures (IB)
    • Authoring and amending IBs for LCCC manufactured investigational products
  • Clinical translation of LCCC-developed products
    • Aid in concept development for in vitro companion diagnostics
    • Collaboration with the Advanced Cellular Therapeutics (ACT) Facility and other UNC Good Manufacturing Practices (GMP) Facilities
  • Supporting LCCC Sponsor Responsibilities
    • Guidance
    • SOP development
    • Compliance
    • Aid with interactions with the Institutional Conflict of Interest (COI) Board and the Office of Technology Transfer
  • Clinical Investigator Training

 Who Can Help You with What

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Our Team