Because of the lingering pandemic health crisis and need to digitally modernize clinical research, Decentralized Clinical Trials (DCTs) are gradually becoming mainstream and therefore in need of a standard regulated framework to structure Digital Tools for clinical investigations.
Health Care and Regulatory Authorities are endeavoring to provide a digital standard for conventional use by both academic and industry clinical research centers by issuing new guidelines.
This Solutions Circle is intended to provide a general overview of digital tools and profile the selection and use of Digital Health Technologies (DHTs) for best practice in clinical trials research as expected by current thinking of the FDA.
Key Takeaways: Understand the general aspects and current trends of DCTs. Definition and current state of DHTs. Understand the key aspects of selection of a DHTs for a DCTs as per guidance. Profiling pivotal description of a submission of DHTs in Clinical Investigations. Understanding the outcomes of DHTs across clinical trials.
Who should attend: Regulatory Affairs Managers, Directors, and Vice Presidents Clinical Development and Clinical Operations Mangers, Directors, and VPs. Clinical Trial Project Managers R & D Product Development Scientist
Learning Objectives:
Understand the key aspects of selection of a DHTs for a DCTs as per guidance
Profiling pivotal description of a submission of DHTs in Clinical Investigations
Understanding the outcomes of DHTs across clinical
