Kathryn G. Davis | Clinical Services Consultant send Kathryn Davis an email
 
Services I can provide:

Experience in developing and managing
  • Service providers (such as, CROs, Central labs, Central imaging, IVRS, EDC) including the outsourcing process from RFP to budget negotiation
  • Investigative site selection
  • Clinical timelines
  • Standard Operating Procedures and Guidelines
  • Clinical section of IND
  • Final Study report
  • Review clinical data
  • Clinical auditing
  • Clinical section of BLA/NDA
  • Clinical section of Investigator brochure
  • Review monitoring reports and follow up on issues documented
  • Assist Regulatory Group with preparation of INDs and NDA/BLA
  • Clinical staff including contractors and regional CRAs