Clinique Research Development

CLINICAL MONITORING AND REPORTING

Our team of experienced CRAs, Clinical Trial Specialists, Project Managers work to ensure that all aspects of the clinical study are managed efficiently and effectively.

We also ensure that the right and welfare of all study participants are not compromised and the quality of data collected are of highest standards.

We oversee the progress of the clinical trials ensuring that they are conducted, recorded, and reported in accordance with the approved protocol, SOPs, GCP, GCLP and applicable regulatory requirements (ICH E6: 5.18) to the highest standards.

Our monitoring visits include feasibility visits, pre-study visits, initiation visits, routine monitoring visits and close out visits.

 

We execute the monitoring plan laid out by the sponsors of a clinical trial. Occasionally, some low-risk studies are monitored almost exclusively by digital devices/remotely except for the initiation and close out visits.

A well written monitoring report is an essential part of documenting a clinical trial, which is why we put as much attention to writing clinical trial reports and take several measures when putting these reports together.

We have an extensive experience in writing monitoring reports, therefore we do not only document issues noted during site visits, but we also follow up on all pending queries from previous visits. Writing effective monitoring reports requires a very vast knowledge of the job, the study protocol, the site, their practices, the sponsor’s procedures, the monitoring plan, and, of course, the regulations.

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