Importance of Remote Monitoring in Clinical Trialsadmin
The scenario of clinical research studies is becoming more complex in view of the ever increasing regulatory compliance demands, increased intricacies and the increasing costs of conducting research. If these constraints have to be tackled then technological optimization is a must. Organizations are more interested in meeting up with the rising costs and deadlines on one hand and ensuring patient safety and regulatory compliances on the other. This has led to the increased importance of remote monitoring for clinical trials.
What is Remote-Based Monitoring in Clinical Trials & How It Works?
Remote-based monitoring is an approach where clinical professionals are not needed to visit the research clinic physically for monitoring purposes; instead they review the data remotely through secure online workspaces. Reviewing data through one such platform like Intralinks VIA is highly useful in this context. Protocol is executed by the research clinics in the normal manner and additionally data is entered in the eCRFs (electronic case report forms). All source documents, medical, labs histories and documents including informed consent forms and the like are uploaded to the secured online workstation. The data can be immediately accessed by the clinical research associate (CRA) and the notification of the same is received by the research clinic.
Once the data is uploaded the CRA compares the source document data with that included on the eCRF and this becomes his ‘monitoring visit’. As the verification of the source data is conducted remotely, this is termed as remote-based monitoring.
Importance of Remote Monitoring for Clinical Trials
Utilizing a partner that provides clinical research services is a must for conducting smooth, hassle-free and successful clinical trials. Among the many services offered, remote-based monitoring is gaining increasing importance because of the several advantages obtained through it.
Effective Collaboration: Remote monitoring facilitates effective collaboration between the sponsors and the clinical research associates with respect to finalizing documents during the site initiation process.
Time Saving:Significantly reduces time taken by research clinics to start screening the study participants
Cost Effective: Site visits may not always be feasible or they can be very costly. In this approach, time if any, needed to be spent by the clinical research associate at the clinical siteis drastically reduced, consequently reducing the budget allocation for the same.
Patient Centric: Highly useful in monitoring patients afflicted with chronic diseases like diabetes as they are not required to be confined to the clinical environment all the time. With patient centricity being the current trend this approach is very favourable.
Focus on Core Study: Clinical research staff and associates find more time to concentrate on the core study rather than restricting themselves on operational checks.
Patient Availability: One of the tiresome processes of clinical research is patient recruitment. Patient dropout which is normally linked to travel inconveniences is another aspect that can affect the successful completion of a clinical trial. Remote based monitoring maximises availability of patients and enrolments in clinical research studies and reduces incidences of patient dropouts too.
Data Quality: Access to data is immediate and transfer of data is most secure. This promotes data quality and brings the element of quality assurance in clinical trials.
Notwithstanding the challenges, remote-based monitoring has made a lot of positive contribution to clinical trials.