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Clinical Trial Monitoring

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Comprehensive clinical trials are required to confirm the safety and efficacy of the treatment regimens and medications. Clinical trial monitoring is essential to ensure the research procedures conform to all the required standards, and the safety monitoring protocols are followed invariably during every phase of the trial.

Clinical Trial Monitoring

How Clinical Trial Monitoring is evolving

Clinical trial monitoring involves the collection and analysis of high-quality data, which has to be recorded and reported in accordance with the standard operating procedures (SOPs), and the principles of good clinical practice (GCP).

As regulations continue to evolve, clinical trial monitoring tools and techniques must also adapt by incorporating the latest available technology.

Key aspects to focus on during monitoring

Adherence to all investigation protocols and assessment schedules

Maintenance of adequate and accurate records

Confirmation of informed consent from participants

Regular and consistent reporting

Regular and consistent reporting of adverse events

Fool proof accounting

Fool-proof accounting for the disposition of study drugs

The Vital Role of Clinical Trial Monitors

Monitors are the heart and soul of clinical studies. Acting as the primary channel of communication between the sponsor and the investigator, monitors have a crucial role to play in clinical trials.

Monitors check data in addition to assisting the investigators make sure the trials are conducted and documented appropriately.

Risk-based Monitoring

Risk-based Monitoring  is a powerful tool for ensuring patient safety and data integrity in a clinical trial that enhances the overall trial quality when applied to study management.

RBM  helps identify potential issues in different areas such as data integrity, compliance, trial conduct, safety, or enrolment. It allows study teams to shift their resources to specific trial-related matters, which reduces the overall volume and frequency of monitoring. RBM improves the quality of the trial data by carefully assessing, monitoring, and mitigating 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 feasibility to site activation and from routine monitoring to closeout visits. 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

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.

  • 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

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