Decentralized clinical trials (DCTs) utilize telemedicine and local healthcare providers, differing from traditional trial models, with remote decentralized clinical trials (RDCTs) enhancing accessibility by moving activities to local settings. There are two main types of DCTs: hybrid, where some activities occur on-site, and fully-remote, where all activities are executed remotely. Benefits of DCTs include increased patient access, improved safety and efficacy, faster trial speeds, and enhanced data accuracy.

1. Decentralized Clinical Trials
THE FUTURE TRIAL PARADIGM
1
Presenter:
C.S. Mujeebuddin
Founder and CEO

2. What is 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.”
 Remote decentralized clinical trials (RDCT) are defined as “an operational strategy
for technology-enhanced clinical trials that are more accessible to [participants] by
moving clinical trial activities to more local settings.”
15-05-2023
www.clinosol.com
2

3. Understanding DCT
15-05-2023
www.clinosol.com
3

4. Flow of DCTs
15-05-2023
www.clinosol.com
4

5. Types of Decentralized Clinical Trials
(DCTs)
 Hybrid: In a hybrid decentralized trial, participants may come on-site for some trial
activities, such as screening and enrollment, while completing the rest of the trial
at home or remotely.
 Fully-remote: Here, every aspect of the trial is handled remotely with the trial
organizer working with sites, direct to patient shipping teams, care nurses, and
more to ensure the trial is run smoothly without the patient ever needing to leave
home.
15-05-2023
www.clinosol.com
5

6. Tools and Services Employed in a
Decentralized Trial
 Telemedicine
 eConsent
 Home Health Coordination and Management
 Centralized Data Collection
 Mobile Devices and Wearables (eCOA, ePRO, etc.)
 Patient Interactive Portals
 IP and Study Supply Logistics
15-05-2023
www.clinosol.com
6

7. Patient and Sponsor Benefits of DCTs
 Increased Patient Access and Less Burden
 Fits Into Patients Daily Lives
 Increased Patient Education and Retention
 Improved Safety and Efficacy
 Increased Speed to Trial
 Increased Data Accuracy and Standardization
 Unified Workflows
 Boost Communication Between All Parties
15-05-2023
www.clinosol.com
7

8. Thank You
 Any Questions??
15-05-2023
www.clinosol.com
8