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Decentralized Clinical Trials
THE FUTURE TRIAL PARADIGM
1
Presenter:
C.S. Mujeebuddin
Founder and CEO
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
Understanding DCT
15-05-2023
www.clinosol.com
3
Flow of DCTs
15-05-2023
www.clinosol.com
4
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
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
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
Thank You
 Any Questions??
15-05-2023
www.clinosol.com
8

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Decentralized Clinical Trials_CSRPL.pptx

  • 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
  • 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