What we do

  • Project Management
  • 21 CFR Part 11-compliant eTMF and Document Management
  • Investigator-specific regulatory services
  • Corporate training program development
  • Monitoring for safety and efficacy
  • Foreign language translation and monitoring
  • Complete site management
  • Recruitment and training of investigational centers and personnel
  • Study coordination
  • Regulatory assurance for device and drug studies
  • Medical writing (including IND/NDA/510K submissions)
  • SOP development
  • Study drug accountability auditing
  • Study Document Design
  • Regulatory Assurance (device and drug)
  • Quality assurance auditing
  • CRO oversight
  • Clinical data and GCP/ICH auditing
  • Corporate training program development
  • Monitoring for safety and efficacy
  • Project management
  • Foreign language translation and monitoring
  • Complete site management
  • Recruitment and training of investigational centers and personnel
  • Study coordination
  • Regulatory assurance for device and drug studies
  • Medical writing (including IND/NDA/510K submissions)
  • SOP development
  • Study drug accountability auditing
  • CRF design
  • Regulatory Assurance (device and drug)
  • Quality assurance auditing
  • CRO oversight