OVERVIEW ON REMOTE CLINICAL TRIAL MONITORING

A BRIEF OVERVIEW ON REMOTE CLINICAL TRIAL MONITORING

Remote Monitoring: Remote monitoring is defined as an off-site evaluation performed by the monitor away from the site at which the clinical investigation is being conducted. In recent years, remote monitoring is a beneficial and viable supplement for clinical studies. In this pandemic, it has become a vital necessity for today’s drug research efforts. Remote monitoring plays a vital connection between the sponsor, clinical research organization, and research site.

Remote site monitoring is one of the innovative methods to ensure the quantity of data which can save time, cost and most importantly, increases the work-life balances of monitors.

Benefits of Remote Clinical Trial Monitoring

By using the digital network, the sites and sponsors in remote clinical trial monitoring can capture the following benefits:

1. Improve and Complete Remote Site Access: By digitally connecting sponsor and site systems, the monitor can securely access the research site’s trial documentation from anywhere and anytime. Sponsors and CRO monitors receive user-based permissions to the studies and sites that they need to manage. This access allows monitors to complete their work remotely without communication, onsite restriction, or travel delays, saving significant time, and reducing overall cost.

2. Efficient Communication Between Site and Sponsor: Most technology systems that enable remote monitoring also include features that allow for streamlined communication like notifications, dashboards, in-app messaging, and email push notifications. These features reduce communication delays from antiquated processes and consolidate all conversations where the work gets done – in the technology system itself. To solve the administrative and compliance challenges introduced by paper, email, and separate systems, the site needs a collaborative system to assess the trial-related documents and to ensure the protection of participant data.

3. Comprehensive Tracking of Site and Study Progress: Monitors can typically set up system alerts and notifying options for document completion and other site activity to eliminate time wasted in communicating or checking for updates. Dashboards create a singular view of site efficiency, study timelines, document completion, and outstanding actions to manage trial activities more effectively.

4. Compliant Processes and Oversight: Compliant technology that complies with 21 CFR Part 11 and HIPAA standards might create a secure environment to complete and protect the clinical trial documents and data. Source documents can be reviewed remotely. Audit trails offer a clear path to track compliance and staff actions.

5. Automatic Document Routing Within and Between Systems: Fortunately, purpose-built remote clinical trial monitoring platforms have identified and addressed this concern by connecting the eTMF and eISF to enable the ability to:

✓ Automatically route Quality Controlled documents to the eTMF

✓ Deploy one-click eTMF binder structures to all sites

✓ Assign and track electronic signatures

✓ Redact, edit and capture data

✓ Update versions of documents in a single place

6. Standardize Repeatable Processes and Workflows: In contrast, with technology driving the repeatable workflows, they can be built into a process once and executed or duplicated in a few clicks. Standardized folder and binder structures can be created in a central folder and duplicated across studies or sites.

Safety monitoring in Remote clinical trial

Nowadays researchers are pairing new tools with traditional biomarker assessments as a way to validate their safety and efficacy. Knowledge and understanding the ability for using digital tools to collect data continuously might result to improve the detection of infrequent events or those that are situation-specific and unlikely to occur during a study visit. The speed at which identifying and reporting adverse and safety events may have an early significant impact on timelines of completion of clinical trials.

Reference

https://florencehc.com/blog-post/why-remote-clinical-trial-monitoring-is-the-new-standard/ 

BY:

R.PRIYANKA (PHARM D) (CSRPL_INT_ONL_WKD_065/0421)

V.AJITH KUMAR (PHARM D) (CSRPL_INT_WKD_066/0221)