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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