Centralized and Decentralized Trials

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The FDA recently defined DCTs as the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. They also clarified that DCTs should not be confused with virtual trials which are based on computer models and do not use real participants but computer programs to model participants to assess drug efficacy and safety during the preclinical phase.

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Many different technologies are available today to communicate with and collect data from study participants remotely. In a hybrid DCT an à la carte approach can be used in any current and future clinical trials. In fact, many of the current global Clinical Trials (phases 2-3) may incorporate a form of a decentralization. Below are examples of such services that can be implored in a study:

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• eConsent

• eCOA (Clinical Outcome Assessment) by the participant, clinician, observer/caregiver

• Web/Online Survey

•  eDiary

• Wearables/Sensors

• Devices (e.g., glucometers)

• Smart Watches

• Local Laboratory collections

• Telehealth visits

• Home healthcare visits

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At DAR, we ensure sites are capable and are trained on the latest technology in order run any DCT trails. Our quality assurance program assess and captures risk and puts in a place risk mitigations. Additionally we have adopted our services on a similar model as the industry. We have incorporated some the latest technology and streamlined administrative workflow , allowing for both remote and  on-site administrative support, which is lessening the burden on our network sites. Our systems are not used for Patient Data capture but a virtualization of our scope of services. Such examples of our decentralized services as:

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• Electronic Regulatory Binders

• Clinical Trial Management Software

• Budget Management Tools

• Off-site Quality Management.

• Central Recruitment Campaigns. 

• Remote access for Monitors for Source Data Review and Verification​

 

Our Model offers flexibility for the Investigators while still maintaining essential site operations.