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When There’s No Registry: Building Rare Disease Evidence That Supports Regulatory Scrutiny

Trust, Technology, and the Patient-Site Relationship: Q&A with Andrea Valente, uMotif

ACT Brief: Data Provenance and Device Strategy, Cell-Gene Therapy Site Readiness, and Data Harmonization Bottleneck

Clinical Site Readiness for Cell and Gene Therapies: Operational and Supply Chain Challenges as they Scale and as they Expand into the Community Care Setting

Beyond Compliance: Vivalink's Cecilia Xi, PhD, on Data Provenance and Sustainable Device Strategy in Clinical Trials

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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.

In today's ACT Brief, we examine technology's real role in patient-site collaboration, why AI pilot failures stem from organization not innovation, and Novo's weight-loss drug results in competitive comparison.

Most AI pilots in drug development fail not from poor technology but from lack of strategic prioritization, organizational readiness, integrated data infrastructure, and disciplined governance, making success dependent on business discipline rather than technical capability.

In a video interview prior to the 2026 DPHARM conference, Andrea Valente, CEO of uMotif, explains why the real technology challenge isn't usability alone—it's making it easier for patients and sites to interact more effectively with each other.

In today's ACT Brief, we examine what patient-site relationships need most at DPHARM, how platform-based AI scales across workflows, and FDA's approval of a gene therapy for a rare childhood syndrome.

In a video interview prior to the 2026 DPHARM conference, Andrea Valente, CEO of uMotif, shares what she expects to be at the center of the conversation—from building trust between patients and sites to where AI may and may not have a role in that relationship.

A platform-based approach connects AI across workflows, data and governance, helping life sciences organizations move from isolated wins to real scale.

In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.

The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.

Why clinical development’s next AI bottleneck is not the model, but the system around it.

In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.

FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines
The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.

A Syneos Health-announced study from Tufts Center for the Study of Drug Development finds no single sourcing model consistently outperforms others, pointing instead to vendor coordination, governance, and fit-for-purpose design as the real performance drivers.
























