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.