Andy Studna, Senior Editor

In this video interview, Kent Thoelke, CEO of Paradigm Health, describes how manual eligibility screening and swivel-chair data entry force community sites to trade billable patient care for research, and why that burden is so hard to absorb.

In today’s ACT Brief, we examine how cost barriers and site infrastructure limit participation in community trials, why endpoints should reflect what patients actually experience, and how the FDA expanded a prostate cancer combination to an earlier treatment setting.

In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patient cost barriers and site infrastructure challenges must be solved together to close the participation gap in community and rural clinical trials.

In today’s ACT Brief, we examine why the future of AI in trials is a trusted orchestration system rather than a single model, how coordinators rate eSource-enabled workflows, and what a bipartisan bill proposes for reusable trial networks.

The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.

In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, identifies three recurring failure modes in AI governance frameworks—and explains why responsible AI must be an ongoing operating discipline, not a one-time approval gate.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, explains why the real advantage of faster data isn’t speed—it’s shortening the distance between signals, human judgment, and the next best action.

In today’s ACT Brief, we examine how AI is moving into continuous clinical operating models, how trust is built into oncology real-world evidence, and how the FDA approved a self-administered option for thyroid eye disease.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, explains why the shift from narrow AI tools to a continuous learning clinical operating system is where the real operational value lies—and what it takes to get there.

In this Q&A, Saamir Pasha and Carole Berini, PhD, of Ontada discuss what it takes to harmonize fragmented oncology data into reliable real-world evidence, how lab markers can proxy for missing functional status data, and where the biggest remaining barriers to consistent RWE generation lie.

In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.

Clinical trial endpoints define what success looks like, but patients and caregivers are rarely the ones setting that definition, and the gap between what trials measure and what patients actually value is showing up in post-approval evidence, regulatory submissions, and the design rooms where protocols are written.

In today’s ACT Brief, we examine what it will take to scale EHR-to-EDC connections for real-time trials, how the FDA is reimagining rare disease drug development, and why oncology real-world evidence still faces persistent data barriers.

A new white paper and public engagement process outline the FDA’s commitment to building fit-for-purpose evidentiary standards, stronger patient voice integration, and greater regulatory predictability across rare disease drug development and review.

In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from site systems to sponsor platforms, and how Roche is licensing a novel obesity target from a biotech pioneer.

The partnership gives RealTime's network of more than 3,000 research sites access to the Archer platform for direct, automated data transfer from eSource to any sponsor electronic data capture system or data destination.

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, identify three persistent obstacles to consistent real-world evidence generation in oncology—inconsistent data capture, structural data limitations that modeling alone can't fix, and the need for earned generalizability through deliberate multi-site validation.

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, describe what operationalizing regulatory-grade quality frameworks requires—and why fit-for-purpose evidence generation is a transparency and documentation discipline, not just a data cleanliness exercise.

In this video interview, Carole Berini, PhD, of Ontada, explains how validated proxies for variables like ECOG performance status can recover not just sample size but the representativeness of hard-to-reach patient populations in real-world oncology studies.

In today's ACT Brief, we examine proportionate analysis frequency in RBQM, how to build trust into real-world evidence foundations for cancer trials, and how rare disease developers monetize regulatory success.

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, explain how building trust into the data foundation—through source lineage, standardization, and reconciliation—is what makes reliable real-world evidence generation in oncology possible.

In today's ACT Brief, we examine how AI surfaces design flaws before enrollment, why site training readiness depends on learning science, and the priorities defining next-generation weight-loss therapies.

In this Q&A, Claire Riches, VP of clinical solutions at Citeline, discusses how AI is transforming endpoint selection and protocol pressure-testing, what data inputs matter most for realistic enrollment planning, and why the tools are more accessible than most sponsors assume.

In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can make enrollment more predictable.

A new FDA Voices post from the agency's acting chief of staff details completed milestones and upcoming priorities across complete response letter disclosure, application lifecycle transparency, new approach methodologies, labeling, and inspectional records.

In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.

Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.