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In today's ACT Brief, we examine why payment inconsistency persists despite industry awareness, why inspection readiness must be built throughout execution not assembled at submission, and FDA approval of the first disease-specific treatment for a rare blood disorder.

Inspection readiness reflects how a program was actually run throughout its lifecycle, not what can be assembled at the end, making pre-submission remediation itself a signal of absent oversight rather than proof of it.

In this video interview, Patrick Mizer, chief technology officer at Ledger Run, traces the fragmented contracts, outdated benchmarks, and disconnected systems behind payment inconsistency—and explains why the industry has historically accepted the complexity rather than addressed it.

In today's ACT Brief, we examine how payment reliability has become a competitive differentiator at high-performing sites, what a truly strategic lean development model looks like, and a licensing deal for a next-generation obesity therapy combining Phase I data with preclinical validation.

In this video interview, Patrick Mizer, chief technology officer at Ledger Run, explains how the shift from competing for patients to competing for high-performing sites has made payment reliability an operational brand—and a real factor in which sponsors get prioritized.

In this Q&A, Stella K. Vnook, PhD, CEO and executive chair of Kaida BioPharma and founder and CEO of Aviva Ventures, discusses how a trifecta of funding pressures is reshaping early-stage clinical development, why commercialization readiness can no longer wait until late-stage, and what a truly strategic lean development model looks like in practice.

In today's ACT Brief, we examine the three conditions required for AI-driven trial acceleration to work at scale, why agentic AI will force CRO operating model reckoning, and two major platform collaborations advancing discovery speed.

Agentic AI will put the CRO operating model to the test—and force the efficiency and accountability questions the industry can no longer avoid.

In this video interview, Amber Hill, PhD, founder and CEO of Research Grid, outlines the three conditions required for AI-driven trial acceleration to work at scale: broad AI literacy, shared boundaries around where it can be applied safely, and incremental adoption of purpose-built tools across the entire ecosystem.

The acquisition follows Lindus Health's pivot to a therapeutics focus and gives Curavit a unified operational footprint across North America and Europe for decentralized, hybrid, and traditional clinical trials.

In this video interview, Amber Hill, PhD, founder and CEO of Research Grid, explains why most trial failures are fundamentally administrative problems—and why patient sourcing, site feasibility, and back-office data capture are where AI delivers the fastest and most meaningful wins.

In today's ACT Brief, we examine why AI architecture and ownership matter more than model sophistication in clinical development, how the FDA proposes to regulate generative AI-enabled medical devices, and a new leadership appointment at the agency

A new discussion paper from the FDA's Center for Devices and Radiological Health proposes a two-axis risk framework and competency-based evaluation approach for generative artificial intelligence-enabled medical devices.