Medical Consulting Services:

Pre-clinical and clinical program development, operations management and recruiting.

 

CAPABILITIES INCLUDE:

  • Strategic Planning (Corporate, Clinical, & Regulatory)
  • Protocol Design (Phases I – IV – Drugs, Biologics and Devices)
  • Medical & Safety Monitoring
  • Medical Affairs (Post-Mktg) Program Development & Copy Review (DDMAC Compliance)
  • Regulatory Affairs - FDA & EU expertise (pre-IND, IND, IDE, BLA, 510k, PMA 501 (6)2 – filing, reporting and associated processes
  • Clinical and General Operations Management
  • Team Assessment & Building
  • Medical Writing
  • GCP Auditing and  Compliance
  • DSMB Committee Formation or participating member
  • IBC Committee Formation or participating member
  • IRB Committee member
  • Promotional Materials(s) Review Committee (PRC) Formation or Member of

 

Areas of Clinical Trial/Development Experience:

 

THERAPEUTIC CATEGORIES:

  • Oncology
  • Gene Therapy
  • Vaccines
  • Medical Devices
  • OB/GYN
  • GI
  • GU
  • Women’s Health
  • Intranasal Drug Delivery
  • Cardiac
  • Neuro / CNS
  • Pediatrics
  • Nanotechnology Applications