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What are Decentralized Clinical Trials (DCTs)?

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The Opportunity of Decentralized Trials

The growing interest in Decentralized Clinical Trials (DCTs) reflects a deepening industry-wide focus on patient-centricity coupled with the availability of remote data capture technologies that enable participation in trials from patients’ homes and other non-traditional settings. DCTs stand to reduce the patient burden and enhance diversity through greater flexibility while offering the potential for trial acceleration and improved patient enrolment. Trials may be fully decentralized, or, more commonly, take a hybrid approach combining remote elements with traditional site-centric approaches. During the pandemic, operational necessity significantly boosted the existing trajectory towards decentralization, and the number of trials incorporating decentralized components has increased from 250 trials in 2012 to 1,291 trials in 2021.

New Workflows, New Challenges

Despite the promise of these innovative approaches, decentralized trials present unique challenges in handling non-traditional workflows and grappling with the sheer volume, variety and velocity of incoming data. DCTs also impose changes to ways of working for sites with the requirement to manage new data capture technology like devices and sensors and support their use by patients. These specific considerations for DCTs and hybrid trials include:

  • Designing robust data capture solutions to accommodate decentralized trial elements, starting from protocol design.
  • Ensuring quality and reliability of data derived from disparate sources.
  • The need to streamline collection, aggregation, and review of data from non-traditional sources.
  • Requirement for sponsors and sites to monitor both patient and operational data in near real time and ensure compliance and efficiency.
  • Achieving standardization of distinct data types to ensure meaningful analysis.

Our Solutions

eClinical Solutions brings together clinical trial expertise, technology, and services to help sponsors navigate the data complexities of designing and implementing decentralized trials.

Our unique value proposition includes:

  • Up-front statistical input into protocol design and data collection approach to ensure successful downstream analysis for decentralized and hybrid trials.
  • Expert guidance on incorporating DCT elements leveraging best practices, lessons learned and therapeutic area experience.
  • Unified clinical data infrastructure through elluminate® to seamlessly acquire, aggregate, review, manage and analyze disparate traditional and DCT data sources.
  • Team of data strategists with a track record of collecting, managing, and analyzing large volumes of data from diverse sources.
  • Expertise in data capture with ability to translate the most complex protocols into robust data collection solutions.
  • Application of Artificial Intelligence, machine learning, automation and risk-informed approaches across the data life cycle to enable focus on the critical data that matters.
  • An eClinical Solutions Center of Excellence for External Data developing best practices for standardization and vendor relationships to maximize the value of all external data types.
  • Team experience creating integrated solutions for fully decentralized and hybrid models with technology components including remote site activation, recruitment portals, eCOA, ePRO, and eConsent.
  • Adept at developing processes and workflows to maximize the benefits of technology for non-conventional data processes.

2024 Industry Outlook: Driving Tomorrow’s Breakthroughs with Clinical Data Transformation