Digitally Enabled Clinical Trials
Digitally enabled clinical trials with digital health technologies are making a rapid advance in clinical trials. One of the main reasons for such advancement lies in the great opportunity to radically transform the way clinical trials are conducted. Furthermore, it enables the clinical trial paradigm shift from site-centric to patient-centric clinical trial model.
The benefits of digitally enabled clinical trials are reduction of the patient burden, improved drug adherence, closer engagement with patients, and high-quality, faster, and more frequent data collection.
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Digital Health Technologies
Digital health technologies, like smartphones, smartwatches, and other body-worn or in-house sensors can help reimagine clinical trials by aiding the diagnosis and remote objective monitoring of a patient’s disease symptoms. An increasing number of researching pharmaceutical organizations are striving to adopt and apply emerging digital technologies in their clinical trial conduct process, following a three-step process: Digital Enablement, Digital Transformation, and Digital Reimagination.
However, broader digital health technology adoption is yet to reach its full potential due to challenges around patient privacy, lack of sufficient validation for digital endpoints, lack of transparency for calculation of endpoints, challenges related to patient adherence, and the burden of wearing and using devices, as well as operational and data transfer challenges, and regulatory unknowns .
Why work with intilaris to digitally enable clinical trials
Intilaris supports research sponsors to establish, strengthen and finalize their roadmaps to digitally enable clinical trials through:
- Digital Enablement
- Digital Transformation
- Digital Reimagination
Our extensive and proven experiences in clinical standards, and clinical development planning and conduct enable us to effectively support our customers in areas of:
- Digital health technologies
- Digital biomarkers and endpoints
- Technology data and metadata standards
- Patient engagement