Decentralized Clinical Trials: Book Of Case Studies

The FDA characterizes a decentralized clinical trial (DCT) as a clinical investigation in which some or all trial-related activities take place at a location separate from the investigator's site. This definition aligns with Medidata's vision of decentralized trials, which revolve around putting the patient at the center of the study. With today's technologies, patients are more empowered than ever to engage remotely in their trial activities, enhancing their overall experience, and enabling sponsors to conduct more efficient and intelligent trials driven by high-quality data.

Medidata boasts a longstanding leadership position in the DCT realm, having initiated the industry's first decentralized trial and the largest decentralized trial to date. Over two decades of continuous innovation have resulted in the most comprehensive patient- and site-centric solutions in the industry while maintaining a secure and scalable approach. The company's ecosystem consists of tools, people, and processes that enable patients, research sites, and study sponsors to participate, contribute to, and monitor any clinical trial. These efforts are notably supported by risk-based monitoring technology and advanced analytics, which enables Medable's teams to enhance and refine clinical decision-making while ensuring patient safety, regardless of location.

For those considering adopting or transitioning to decentralized trials, Medidata's professional services experts are available to offer tailored guidance, advising on the technologies to implement, the extent of on-site versus decentralized activities, and the operational adjustments required for each unique scenario. This problem-solving approach, coupled with a focus on human-centered solutions, helps teams formulate a strategy customized to their specific needs and those of their clients.

Below, readers will find a collection of case studies showcasing Medidata's capabilities in decentralized trials, including the industry's first fully decentralized megatrial, ADAPTABLE. Additionally, these solutions are designed to fortify DCT offerings and assist all stakeholders throughout the entire trial process.