Andy Studna, Senior Editor

Senior FDA leaders outline concrete steps to strengthen inspection coverage and data integrity review as the globalization of clinical research strains the agency's oversight capacity.

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain why time savings dominates the eNPV model for RBQM—and what that means for how sponsors should frame the internal case for investment.

In today's ACT Brief, we examine why many trial failures trace to human readiness gaps rather than process design alone, how CRO consolidation expands early-phase capacity, and how AI-enabled patient matching is reshaping recruitment economics.

The all-cash transaction adds a good laboratory practice-compliant bioanalytical laboratory, a 200-bed clinical pharmacology unit, and a biospecimen storage facility to Fortrea's early-phase development network.

In today's ACT Brief, we examine how eNPV modeling and real-world data finally put numbers on RBQM value, why static budgeting masks true site costs, and GSK advancing an mRNA flu vaccine candidate to late-stage testing.

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain how combining real-world deployment data with eNPV modeling finally made it possible to put a number on the financial value of RBQM—and why oncology was chosen as a conservative starting point.

In today's ACT Brief, we examine why operating model redesign must precede agentic AI deployment, how integrated platforms compress operations toward accountable teams, and BioNTech's decision to terminate a colorectal cancer mRNA trial.

Agentic AI is arriving in clinical operations with genuine capability to absorb administrative work, but the organizations that will realize lasting value are those willing to redesign accountability structures, financial workflows, and operating models before deploying the tools on top of them.

In today's ACT Brief, we examine why 80% of sites operate on minimal cash reserves, how biomarker-informed enrollment risks excluding viable patient populations, and the growing role of predictive maintenance in preventing batch losses.

In this video interview, Patrick Mizer, chief technology officer at Ledger Run, addresses the reality that 80% of sites operate on six months or less of cash—and explains why growing investment in agentic AI and workflow modernization signals that the industry is starting to treat payment infrastructure as the priority it deserves.

In today's ACT Brief, we examine how unpredictable payments damage site retention, why rapid AI deployment without validation creates regulatory risk, and China's growing dominance in early-stage drug discovery.

In this video interview, Patrick Mizer, chief technology officer at Ledger Run, explains how unpredictable payments erode site relationships over time—and why operational excellence in payments is becoming increasingly important to landing and retaining the best investigative sites.

In today's ACT Brief, we examine where agentic AI delivers immediate wins in site payments, how botanical therapies can earn pharmaceutical credibility, and the connected financial systems reshaping trial operations.

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joel Stanley, CEO of AJNA BioSciences, about why botanical therapies need pharmaceutical-grade standardization and clinical evidence to earn physician trust and insurance coverage.

In this video interview, Patrick Mizer, chief technology officer at Ledger Run, describes how agentic AI is being applied to invoice processing—one of the most labor-intensive bottlenecks in site payments—and what meaningful improvement actually looks like in practice.

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.

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.

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.

In today's ACT Brief, we examine where trial failures actually originate and where AI delivers fastest wins, how CRO consolidation creates global operational scale, and the first FDA-approved treatment for a rare progressive bone disorder.

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.

In this video interview, Amber Hill, PhD, founder and CEO of Research Grid, makes the case that AI architecture—who built the model, who owns the data, and how outputs are traced—is the most important due diligence sponsors can do before adopting any AI tool in clinical development.

In today's ACT Brief, we examine which Phase I administrative processes are most ripe for AI automation, how sponsors should balance investor demands for real-time data against scientific rigor in capital-constrained trials, and a major CRO's expanded artificial intelligence partnerships.

New collaborations with Causaly, Databricks, and Microsoft anchor a broader push to embed artificial intelligence directly into clinical trial decision-making and operational workflows.