Applied Clinical Trials' 2025 State of the Industry Survey

Cell and gene therapy access expands into community care settings only when operational coordination, site readiness, and supply chain standardization become first-order priorities equivalent to manufacturing capacity, requiring standardized processes, digital integration, and distributed logistics networks.

Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.

AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, about why defensible trial data depends on traceability, platform ownership, and device strategy long after a study ends.

Site training effectiveness depends on readiness at first-patient-in, requiring learning-science design principles around performance focus, cognitive load reduction, progressive sequencing, and spaced retrieval practice rather than training completion metrics or content volume.

Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only as fast as the infrastructure, data, and cross-functional decisions required to deliver it.

In this video interview, Claire Riches, VP of clinical solutions at Citeline, offers practical guidance for clinical operations teams beginning their AI journey—making the case that the tools are more accessible than many assume and that waiting to start is a competitive risk in itself.

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains how AI is shifting trial risk management from reactive to proactive—enabling sponsors to pressure-test protocols and anticipate pivots before a single patient is enrolled.