Inspectable & Compliant eTMF Archiving for Closed Studies

In rare disease drug development where no registry or natural history dataset exists, real-world evidence quality depends on treating evidence engineering as a design-stage decision, defining intended regulatory use and standardizing endpoints, harmonization, and data provenance upfront rather than reconciling gaps after collection.

In this Q&A, Andrea Valente, CEO of uMotif, discusses what it takes to build genuine trust between patients and sites, why making technology easier to use isn't the same as making patient-site interaction more effective, and where the industry is still falling short in its push toward patient-centered trial design.

In today's ACT Brief, we examine why defensible trial data depends on traceability and platform ownership, what CGT site readiness requires as therapy moves to community care, and why data harmonization is AI's primary bottleneck.

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.

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.

In today's ACT Brief, we examine understanding the patient journey from end to end, whether decentralization reduces site burden or just shifts it, and why nine European drugmakers are sounding urgent alarms.

Decentralized trial models have demonstrated real gains in enrollment performance and patient access, but operational switching costs, fragmented technology stacks, and unresolved gaps in the patient-site relationship raise a question the industry has been slow to confront directly.

In a video interview prior to the 2026 DPHARM conference, Andrea Valente, CEO of uMotif, explains why truly understanding the patient journey from beginning to end—and building that understanding into both study design and data collection tools—remains one of the industry's most important unfinished tasks.