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.
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.
How to generate reliable Phase I evidence in a capital-constrained environment.
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.
Faster, more efficient clinical trials depend on structural alignment in how sponsors, CROs, and research sites plan and execute studies together.
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.
Clinical research associates are evolving from compliance-focused manual monitors to data-enabled strategic site partners, but organizations need analytics training, clear operating models, and active change management to make the shift stick.
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.
New eNPV modeling applied to operational data from an AI clinical monitoring agent finds ROI multiples as high as 82x, with time savings and monitoring cost reductions identified as the primary value drivers.
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joseph Kim, Chief Strategy Officer at ProofPilot, and Lauren Briggs, Chief Customer Officer at ProofPilot, about why completing training is not the same as being prepared to execute a protocol.
In today's ACT Brief, we examine new strategies for breaking efficacy plateaus in IBD through combination approaches, why clinical research teams lose talent at the early-career stage, and how FDA's Priority Review Voucher program is reshaping rare disease capital flows.
Clinical research coordinators face early burnout driven by gaps between job expectations and operational reality, inadequate mentorship structures, and fragmented technology environments that compound insufficient onboarding and deplete resources needed to sustain engagement.
