In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how FDA inspection findings at APAC sites compare with those in the US and Europe, and why the common issues, such as informed consent versioning, are not unique to the region.

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how regulatory reform and inspection data contradict the view that APAC sites are slower or lower quality, and why sponsors need to update their assumptions.

In this Q&A, Kent Thoelke, CEO of Paradigm Health, discusses why participation gaps in community and rural settings come down to both patient cost barriers and site infrastructure, how legacy workflows weigh on community clinics, and what policy and technology changes it would take to make clinical research a real care option for more patients.

Neuroscience trials struggle to show benefit because symptoms are subjective and variable, and eCOA strengthens dossiers by standardizing ClinRO administration, capturing outcomes in real time to reduce recall bias, and adding patient and caregiver perspectives that clinician scales miss.

Community participation gaps look less like a question of patient willingness and more like a financing and infrastructure problem that no single bill has yet solved.

In this video interview, Kent Thoelke, CEO of Paradigm Health, calls for safe harbor protections, CMS reimbursement safeguards, and funding mechanisms modeled on EHR meaningful use to help community and rural institutions participate in research on par with academic centers.

In this Q&A, E.K. Koh, chief product officer at Suvoda, discusses what separates a trustworthy AI assistant from one that adds risk, why curated clinical knowledge matters more than general-purpose flexibility, and what safeguards must be in place when assistants move from answering questions to taking actions in clinical trial systems.

The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.