Clinical Trials Monitoring is the Quality Control (QC) and Quality Assurance (QA) activity where expert Monitors must ensure that the trial procedures and data collection methods meet the regulatory guidelines, approved protocol, ethical guidelines, and also the SOPs of the Sponsor, CRO and Hospital.
A well trained and experienced monitor must have thorough knowledge of the above. They must also be able to ‘multi-task’, undertake & manage travel and must possess strong interpersonal skills because they act as a major link with internal departments and the study staff of the site(s).
We at Consortium Clinical Research, have commendable experience in undertaking both domestic and international monitoring assignments. We ensure ‘zero tolerance’ to regulatory and quality issues without affecting the smooth conduct of the study at each site (be it in metro cities / in smaller towns) is maintained.
As observed, some of the domestic / international Sponsors also face logistical problems of devoting man-power to travel across the country and perform their monitoring responsibilities as per their requirements. In such situations, we extend our monitoring services to our clients by deploying our in-house monitors.