Clinical trials conducted with a remote or decentralized approach, utilizing digital technologies, mobile devices, and virtual communication methods to enable participation from diverse geographic locations, reducing the need for physical visits to clinical sites.
A digital platform or online portal where trial-related activities such as patient enrollment, informed consent, data collection, and monitoring are conducted remotely.
The process of collecting and analyzing clinical trial data in real-time from participants’ homes using wearable devices, mobile applications, and other remote monitoring technologies.
The use of telecommunications technology to provide remote medical care, enabling virtual consultations between participants and healthcare providers without the need for in-person visits.
Obtaining participants’ consent for participation in clinical trials remotely through electronic signatures, video conferencing, or other digital means, in compliance with regulatory requirements.
Electronic devices worn by participants to collect physiological data such as heart rate, activity levels, and sleep patterns, providing objective measurements for assessing endpoints in decentralized clinical trials.
The electronic capture of clinical trial data directly from participants using mobile devices or web-based platforms, allowing real-time data collection and analysis from diverse geographic locations.
A clinical investigator who oversees trial activities remotely, communicating with participants, conducting virtual visits, and managing trial-related tasks through digital platforms.
Utilizing digital systems and logistics solutions to manage the distribution of investigational drugs, study materials, and supplies to participants’ homes or local pharmacies, ensuring timely delivery and adherence to protocol requirements.
Adherence to regulatory guidelines and standards governing decentralized clinical trials, ensuring data integrity, participant safety, and ethical conduct throughout the trial process, while leveraging innovative technologies to enhance efficiency and accessibility.