Clinical Trial Monitoring
How Clinical Trial Monitoring is evolving
Key aspects to focus on during monitoring
The vital role of Clinical Trial Monitors
For this reason, thoroughly trained monitors with right scientific and clinical knowledge are always a huge asset. Apart from assisting the investigators to make sure the trials are conducted and documented appropriately, monitors also verify the true existence of the information collected by cross-checking the source documents.
How Clinvigilant monitors can add value
The select group of monitors from ClinVigilant dedicates itself to providing an exceptional level of quality data review while thoroughly engaging themselves with study sites, providing additional advantages.
Our monitors are highly experienced in Phase I-IV clinical studies and proficient in analgesic clinical trials. Each of them is adept in providing GCP-focused data review with flexible scheduling to ensure proper on-site time. Overall they ensure fast turnaround time for site visit reports.
The vital role of Clinical Trial Monitors
When it comes to improving the conduct of clinical trials across all phases, Risk-based Monitoring has an enormous potential that is duly recognized by regulatory authorities. It is a powerful tool for ensuring patient safety and data integrity in a clinical trial, and enhances the overall trial quality when applied to study management.
RBM uses advanced tech-tools to identify potential issues with various clinical trial aspects such as data integrity, compliance, trial conduct, safety, and even enrolment. It focuses on high-value tasks that allow study team to shift their resources on specific trial-related matters, which reduces the overall volume and frequency of monitoring. While reducing data reviews in lower-risk studies, and in lower-risk periods of a higher-risk study, RBM improves the quality of the trial data by carefully assessing, monitoring, and mitigating the risks.
VCTM is a relatively new method of clinical monitoring that improves operational efficiency by deploying IT-based tools like apps, electronically monitoring devices, etc. Virtual monitoring optimizes site and CRA time while reducing the cost and time associated with on-site monitoring visits. It also facilitates site monitoring during local travel restrictions due to the pandemic or any other reason.
Our monitoring team meticulously conducts all monitoring activities remotely. From site qualification to site activation and from routine monitoring to closeout visits, the activities are accomplished by utilizing advanced web-based technology. For instance, the team accesses the site’s EMR remotely or enables the site to redact, before sending paper source electronically to a secure location.
How Clinvigilant monitors can add value
Our monitors are highly experienced in Phase I-IV clinical studies and proficient in analgesic clinical trials. Each of them is adept in providing GCP-focused data review with flexible scheduling to ensure proper on-site time. Overall they ensure fast turnaround time for site visit reports.
- Clinvigilant Research monitors have considerable experience with both outpatient and inpatient records and procedure notes
- Our monitors are also trained in control response reduction and the administration of questionnaires.
- The advanced clinical trial monitoring tools from Clinvigilant add to our monitors’ capability to efficiently record and share the information with site-level staff
- Our monitors perform on-site clinical trial monitoring visits throughout the length of the study to:
- Oversee the collection of data
- Review clinical laboratory results
- Source case report forms and documentation
- Resolve data queries
- Oversee the collection of data
- Confirm regulatory compliance
