Clinical Affairs Solutions

xFDA Experts can complement your organization by providing diverse clinical affairs solutions, including planning and executing clinical trials which will withstand the review and examination of the FDA.

xFDA provides the following Clinical Affairs Services.

  • Expert Services from our Regulatory/Scientists including Statisticians
  • Evaluation of significance   of toxicity testing to projected label claims
  • Clinical Strategies
  • Writing or support with clinical protocol

Pre Clinical Discussions with FDA

  • Pre IDE/IDE/IND Meetings with the FDA
  • cGCP assessment
  • cGMP training
  • Clinical Trial Site Selection
    • Clinical Trial Management
    • Data Management and Monitoring
    • Clinical Report