CLINICAL MONITORING AND REPORTING
Our team of experienced Clinical Research Associates (CRA), Clinical Project Managers (CPM), and Clinical Trial Specialists collaborate diligently to oversee every facet of the clinical study with optimal efficiency and effectiveness.
We also prioritize safeguarding the rights and welfare of all study participants, while maintaining the highest standards for the quality of collected data.
We closely monitor the progress of clinical trials, ensuring adherence to approved protocols, SOPs, GCP, GCLP, and relevant ethics and regulatory requirements (ICH E6: 5.18) with unwavering commitment to the highest standards.
We conduct site/study feasibility visits, pre-study visits, initiation visits, routine monitoring visits, and close-out visits.
We implement the monitoring plan approved by the sponsors of each clinical trial. In some instances, low-risk studies are predominantly monitored remotely, with in-person initiation and close-out visits being the exception.
Writing effective monitoring reports demands a deep understanding of the study protocol, site/sponsor procedures, the monitoring plan, and the regulatory requirements. A well-written monitoring report is integral to documenting a clinical trial, which is why we dedicate considerable attention to the process of compiling these reports. We implement several measures to ensure accuracy and comprehensiveness when assembling visit reports.
With our extensive experience in writing monitoring reports, we not only document issues observed during site visits but also diligently follow up on all outstanding action items post-visits.
