Clinical Trial Monitoring

All our Clinical Research Associates (CRAs) are well-trained and experienced in country specific regulatory regulations and ICH GCP.

Our clinical trial monitoring includes:

  • Site selection and qualification in accordance with Protocol and ICH GCP requirements
  • Recruitment strategy
  • Site initiation
  • Regulatory and Ethics Committee (EC) document preparation and collection, regulatory /EC documentation updates
  • Investigator meeting planning and presentation
  • Site personnel training
  • Ensuring protocol compliance and ICH-GCP adherence
  • Site management
  • Routine site monitoring
  • Drug accountability
  • Data validation
  • Clinical study and material accountability
  • Study Close-out/Site Termination.