Andy Studna, Senior Editor
Articles by Andy Studna, Senior Editor

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In this video interview, Patrick Mizer, chief technology officer at Ledger Run, traces the fragmented contracts, outdated benchmarks, and disconnected systems behind payment inconsistency—and explains why the industry has historically accepted the complexity rather than addressed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

In this video interview, Amber Hill, PhD, founder and CEO of Research Grid, identifies the administrative back-office processes causing the most friction in Phase I trials and explains why purpose-built, traceable AI models are the right tool for addressing them.

In today's ACT Brief, we examine what actually drives the 6- to 12-month timeline reductions envisioned under Operation TrialBlazer, why trial modernization requires structural changes in sponsor-site collaboration, and a major biosimilars commercialization partnership.

In this video interview, Amber Hill, PhD, founder and CEO of Research Grid, explains what hitting the 6- to 12-month timeline reductions envisioned under Operation TrialBlazer actually demands operationally—and where AI-native automation can make the biggest difference earliest.

In today's ACT Brief, we examine the standardization gap that sits between raw data collection and real-time analysis, why regulatory unpredictability is pushing US biotechs to run early trials overseas, and FDA accelerated approval of a new immunomodulatory therapy.

In this Q&A, Raviv Pryluk, PhD, CEO and co-founder of PhaseV, discusses the data standardization bottleneck that sits between raw trial data and real-time analysis, what the FDA's continuous monitoring pilot will require to scale beyond large pharma, and why an ecosystem approach is the only path to making real-time trial oversight a practical reality.

A new survey of 37 US biotechnology executives finds broad preference for conducting first-in-human trials domestically, with regulatory unpredictability and clinical holds cited as the primary drivers of overseas migration.

In today's ACT Brief, we examine why data quality is the ceiling for all other trial modernization efforts, how CRAs are shifting from compliance monitors to data-enabled partners, and recognition of five rising industry leaders shaping pharma innovation.

From point-of-care sample collection to real-world data curation, wearable device integration, and continuous review infrastructure, data quality is not a single problem in clinical trials—it is a layered challenge that manifests differently at every stage of development and demands a different set of solutions at each one.

In today's ACT Brief, we examine why protocol training completion doesn't ensure site execution readiness, how AI clinical monitoring drives measurable financial returns, and structural compliance failures behind rising FDA warning letters.