Kathryn G. Davis | Clinical Services Consultant
4225 Skeffington Court, Southport, NC 28461 | 781-249-8972 | kathryn@kgdavisconsulting.com
Services I can provide within clinical operations:

  • Vendor management (such as CROs, Central labs, Central imaging, IVRS, EDC) including the outsourcing process from RFP to budget negotiation
  • Investigative site selection
  • Clinical timelines as identified by senior management
  • Developing and reviewing Standard Operating Procedures and Guidelines
  • Review clinical data
  • Assist Regulatory Group with preparation of NDA/BLA
  • Developing and reviewing clinical section of Investigator brochure
  • Manage clinical staff including contractors and regional CRAs