Applied Clinical Trials' 2025 State of the Industry Survey

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.

Medical writing capacity pressure is fundamentally a talent development problem, not a technology problem, since hybrid resourcing and AI cannot substitute for the experienced judgment needed to review AI output and mentor the next generation of writers.

Patients don’t experience primary endpoints, so trials that stop at biomarkers and rigid rating scales risk declaring success while leaving daily burden untouched, and digital tools only deliver meaningful evidence when they are co-designed with patients and deployed with restraint.

Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.

In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patients in community and rural settings too often lack access to clinical research as a care option, and how closing that gap could improve outcomes and lower long-term costs.

In this video interview, Kent Thoelke, CEO of Paradigm Health, outlines why anti-kickback guidance and modern EHR-integrated trial matching technology must work in tandem to reach representative patient populations at the community level.

In this video interview, Kent Thoelke, CEO of Paradigm Health, describes how manual eligibility screening and swivel-chair data entry force community sites to trade billable patient care for research, and why that burden is so hard to absorb.