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  • Athinon 6, Sea View Point, Suite 201, 7573 Anafotida, Larnaca, Cyprus
CY +357 99 272782 | GR +30 697 728 9821

Clinical Monitoring

Clinical Trial Monitoring & Best Practices

Clinical trial monitoring is essential to protecting the rights, safety, and well-being of study participants while safeguarding the quality, reliability, and integrity of clinical trial data. At Abrazo Research, our monitoring approach is tailored to the requirements of each study, the applicable regulatory framework, and the identified risks.

Through on-site and remote monitoring activities, our team supports protocol compliance, evaluates study conduct, reviews clinical trial data and essential documentation, and follows up on identified issues. Our objective is to help sponsors maintain appropriate oversight of their studies while supporting participant safety, data quality, and regulatory compliance.

Our Monitoring Practices

  • ✔ Site Initiation and Training

    We support site initiation activities and ensure that investigators and site staff are familiar with the study protocol, applicable procedures, safety reporting requirements, and data collection processes.

  • ✔ Source Data Review and Verification

    We review source records and clinical trial data, as defined in the monitoring plan, to assess data accuracy, completeness, consistency, and traceability.

  • ✔ Safety Reporting Oversight

    We support the identification, documentation, and appropriate escalation of adverse events and serious adverse events, in accordance with the protocol, applicable requirements, and agreed safety reporting responsibilities.

  • ✔ Protocol Compliance

    We assess site adherence to the study protocol, identify deviations, and support appropriate documentation, escalation, and follow-up of identified issues.

  • ✔ Data Integrity and Quality Control

    We review clinical trial data and relevant documentation to identify inconsistencies, missing information, and potential quality concerns, supporting timely resolution and reliable study outcomes that reach trials demands until site close-out requirements.

  • ✔ Regulatory and GCP Compliance

    We conduct monitoring activities in accordance with the applicable regulatory requirements, Good Clinical Practice (GCP), the study protocol, and the approved monitoring plan.