CRO Products and Services

Clinical Monitoring

KRGI commits to provide sponsor with highly qualified regional based Clinical Research Associates which substantially reduces the overall cost of the project and ensures its timely completion. We have experienced staff in most geographical regions. This sets KRGI apart from other CRO-s that might not have such extended capabilities.

KRGI CRA-s perform comprehensive site management and monitoring activities to include the following types of monitoring visits:

  • Pre study qualification visits
  • Initiation visits
  • Interim monitoring visits
  • Close out visits

All activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with all applicable regulations and protocol requirements.

  • The paramount responsibility of KRGI CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity.

In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused.

In summary the KRGI CRA plays a major role in the successful conduct of a study. The relationship developed between the CRA and the site staff is such that there is a focus on open effective communication with the CRA providing training and support thus ensuring patient safety, data quality and maximizing patient enrolment.

Medical Monitoring:

  • Medical Monitoring (including 24/7 Medical Monitor coverage)
  • Enhancement of regulatory compliance.
  • Clarifying inclusion/exclusion criteria with the investigator.
  • Providing consultation for potential safety issues or medical concerns regarding the clinical study.