Decentralized monitoring (DM) in clinical trials is a relatively new approach to monitoring that is becoming increasingly popular. DM involves the use of technology and remote monitoring methods to monitor the conduct of clinical trials, as opposed to the traditional on-site monitoring approach. Under DM, monitoring activities are conducted remotely using electronic data capture (EDC) systems, risk-based monitoring tools, and other technologies. This allows the monitoring team to access and review trial data in real-time, without the need to be physically present at the trial site. DM can include a range of activities, such as remote source data verification, central review of imaging data, and remote monitoring of electronic health records. There are several benefits to DM. First, it can reduce the burden and costs associated with on-site monitoring, such as travel expenses and time spent away from the office. DM can also allow for more frequent monitoring and earlier detection of issues, as monitoring activities can be conducted in real-time. Additionally, DM can increase patient safety and improve data quality, as remote monitoring tools can be used to identify potential safety concerns or data inconsistencies more quickly. However, there are also some challenges associated with DM. For example, there may be concerns about the security and confidentiality of trial data when accessed remotely. Additionally, DM may not be suitable for all types of clinical trials, and there may be regulatory or legal requirements that need to be considered when implementing DM.

1. Welcome
DECENTRALIZED MONITORING IN CLINICAL
TRIALS
Name: Afrah Ahmed
Qualification : Pharm D (V Yr)
Student ID: 015/012033
5/5/2023
www.clinosol.com | follow us on social media
@clinosolresearch
1

2. INTRODUCTION
What is Decentralized clinical trials (DCT)?
• Decentralized clinical trials (DCT) are defined as studies “executed through
telemedicine and mobile/local healthcare providers, using processes and
technologies differing from the traditional clinical trial model.
• DCTs are the trials where the patients cater remotely and data is taken by
using technologically advanced equipment.
• Protocols are designed in a way that all trial activities can be performed at
patients’ home or at a remote location.
• Patients have to visit the site on rare occasions only.
• Hybrid trials are good solutions for complex projects.
5/5/2023
www.clinosol.com | follow us on social media
@clinosolresearch
2

3. Monitoring of DCT
5/5/2023
www.clinosol.com | follow us on social media
@clinosolresearch
3

4. Technology Used
• Cloud Computing (To Store, communicate,
and integrate the data)
• AI & ML (To Do the Analytical Part, To
generate data through Stats
• MS Office 365 (To record important
information on real-time
• Tablet and Wearable Trackers (To Capture
Vital and real-time info.)
• eCRFs (Small Office Team needs to
manage the important parts)
• Tab to eCRF Integration (Need to do
for Most of the Subject Level Records
It serves as a Source and directly
integrated to eCRF)
5/5/2023
www.clinosol.com | follow us on social media
@clinosolresearch
4

5. Cont…
• SAE Monitoring through Virtual Pl Calls (Helpline Number for any immediate
Assistance and Data Capture)
• IVRS/IWRS Reminders for Visits to be conducted
5/5/2023
www.clinosol.com | follow us on social media
@clinosolresearch
5

6. How can we contribute in
DCT
• By Creating Analytical tools, we may be very helpful in updating the CL Team on
a real-time basis
• Central Monitors can learn a few techniques and need to train the Nurse and
pharmacists about masking the data and any other legal implications (If Any)
based on Country regulations. They can review and evaluate most of the trial
data remotely.
• We can also manage the SAE documentation and subject helpline activities
remotely from India, we can customize our role for DCT as per the requirements
like access providers, training providers, QC reviewers, and many more.
5/5/2023
www.clinosol.com | follow us on social media
@clinosolresearch
6

7. Conclusion
• Data that we produce will have a great weightage to manage the complicated
health issues
• The Data can be able to work on AI ML Bot training and to train the new doctors
• Patient history data will be available in just one touch to any Physician for better
treatment and evaluations of underlying disease
• Insurance sector will also open up where we can be able to pitch in and get a good
remuneration by analyzing the Subject Data
• Clinical trials will be within the reach of all communities and populations
• Stats will become more judgmental and clearer Many other Sectors will open up like
Disease spread evaluations in regions, Weather impact on health in the region, How
to overcome a disease spread (planning & strategic thinking), and so on and so
forth.
5/5/2023
www.clinosol.com | follow us on social media
@clinosolresearch
7

8. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
5/5/2023
www.clinosol.com | follow us on social media
@clinosolresearch
8