Adequate Monitoring of Clinical Trials is imperative in assuring safe subjects, quality data and a well-executed study. Clinique Research Services, Inc. provides comprehensive site monitoring including the assurance of protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites. Our CRA’s act as a liaison between the site and the study teams. Monitoring visits are conducted at pre-determined intervals and/or as the study dictates.
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 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.