Data Collection in Decentralized Clinical Trials
Information discussing the transition to DCTs and their challenges, alongside the integration of data collection technology and best practices for sharing DCT data.
Blog
Decentralized & Virtual Trials
Decentralized Clinical Trials – Looking beyond the Pandemic
A look at Decentralized Clinical Trials (DCT) beyond the pandemic-what we’ve accomplished and where we are heading.
Inspection & Audit Preparation in Decentralized Trials
To ensure successful end-to-end execution of a DCT, steps to ensure audit readiness must be taken. We have outlined several areas for consideration to ensure audit readiness from start-up through submission.
Data Integrity Considerations in Decentralized Trials
Collected data from DCTs need to be integrated with other data captured during the course of a clinical trial, and data integrity must be ensured in the absence of source data verification. Two topics will be discussed: how to manage this integration and ensure confidence in the collected data.
Protocol Planning and Design for Quality Decentralized Clinical Trials
Decentralized clinical trials allow a patient-centric approach to data collection and communication compared to traditional clinical trials. While additional planning may be needed to implement a decentralized trial the most important question is the same. What is the research question?
Introduction to Decentralized Clinical Trials
Many terms are used to describe decentralized clinical trials (DCTs) such as ‘virtual’, ‘remote’, ‘site-less’, and ‘hybrid’ but what is the exact definition? The FDA recently defined DCTs as the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. We outline the different approaches to implementing DCTs.
A Roadmap to Designing and Executing a Quality Decentralized Clinical Trial
Decentralized clinical trials (DCTs) are playing a role in an increasing number of drug and biologics development programs. While much has been written about the potential benefits that these trials can bring, our experience in this space has taught us that there are several questions that sponsors should be asking as they consider the end-to-end execution of a DCT.
Conducting Successful Site Qualification Visits using Virtual Solutions
On-site facility evaluations have historically provided us with the insight necessary to determine site performance and viability for our clinical trials. With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate those same meaningful evaluations and assessments, safeguarding patient safety and data integrity.