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.
AbbVie’s head of immunology clinical development, Kori Wallace, MD, PhD, discusses how combination therapies, translational science, and emerging immune-reset approaches could usher in a new era of treatment for inflammatory bowel disease and other autoimmune conditions.
In today's ACT Brief, we examine how to evaluate biotech incubators and accelerators beyond marketing, why clinical trial modernization requires point-of-care data collection, and a precision therapy entering registrational trials for a rare genetic epilepsy.
In this Q&A, Richard Graham, PhD, co-founder and chairman of the board at TruTechnologies, discusses why six decades of manual site-level processes continue to undermine clinical trial execution, what national initiatives like Operation TrialBlazer leave unaddressed, and why meaningful modernization has to start with data collected at the point of care.
In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, offers a frank breakdown of incubators, accelerators, and venture studios—and why biotechs need to ask harder questions about track records and exits before committing to any of them.
In today's ACT Brief, we examine how biotech reaches inflection points on limited capital, how the FDA is restructuring early clinical development to reclaim US competitive standing, and a new combination therapy for treatment-resistant melanoma.
