Clinical Trial Monitoring

For clinical research to succeed, comprehensive clinical trials are required to confirm the safety and efficacy of the treatment regimens and medications. Also needed is a highly professional Clinical Trial Monitoring service that ensures the health and safety of the participants in the research. 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.

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 these protocols continue to evolve, also required to improve concurrently are the methodologies and techniques used to support the monitoring process and professionals to enhance participants’ wellbeing. To address the new regulations and challenges, the clinical trial monitoring tools and techniques also have to change by adopting the latest available technology.

Key aspects to focus on during monitoring

Regardless of the method being followed, the clinical studies monitoring must be performed by qualified monitors on a regular basis to ascertain the following aspects:

Adherence to all investigation protocols and assessment schedules

Maintenance of adequate and accurate records

Confirmation of informed consent from participants

Regular and consistent reporting of adverse events

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 monitoring process. Acting as the primary channel of communication between the sponsor and the investigator, monitors have a crucial role to play in the clinical trials. 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

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

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

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

In order to ensure structural and procedural independence is maintained between our CRO and site monitors report directly to, and are managed by ClinVigilant project managers.

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