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