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.
CRIO’s chief innovation officer, Mike Wenger touches on the two ways sites get AI adoption wrong.
CRIO’s Mike Wenger, speaker at this year's SCRS summit, maps how sites are actually deploying AI post-pilot stage.
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.
Paradigm’s Kurt Mussina discusses why scale should drive operational efficiency, not consolidation into single-site studies.
Paradigm’s Kurt Mussina touches on why he rejects the “site management organization” model in favor of one unified business.
ProofPilot’s Lauren Briggs talks on why sponsors and CROs fail at tech rollouts by skipping change management, and pushes for the industry to judge trial technology by real workflow impact rather than feature checklists.
ProofPilot’s Lauren Briggs touches on why site tech adoption hinges on the first 90 days after rollout, and why tools succeed only when they remove work from a site’s plate rather than adding another login to juggle.
Jennifer Byrne, CEO, Javara touches on why fixing clinical research requires sustained infrastructure investment and workforce development.
Sequoia’s Dan White and Dr. Tom Kreamer touch on why sponsors and CROs should treat a site network as one centralized partnerto speed startup timelines and strengthen execution.
Sequoia Clinical Research’s CEO Dan White and CMO, Dr. Tom Kreamer explain what it takes to merge three site organizations into one network.
Javara CEO Jennifer Byrne talks about the requirements for embedding clinical trials directly into physician practices and why solving the “last mile” of trial participation means building infrastructure at the actual point of care.
Trially CEO Kyle McAllister explains why transparent AI reasoning is essential for trial patient matching.
Trially Co-founder and CEO Kyle McAllister, explains how AI absorbing the bulk of clinical-trial chart reviews can free research sites to focus staff time on higher-value tasks.
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 Episode 3 of The Human Side of Clinical Trials, hosts Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., speak with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about why a well-written protocol doesn’t always translate into consistent execution, and how designing for the way people actually think and learn can reduce site burden and the need for costly unlearning.
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.
Real-time clinical trials require standardized digital data capture at the point of care through scaled eSource-EDC-EHR integration, but progress stalls because competing standards lack regulatory enforcement and one-off system integrations cannot scale beyond single studies without industry-wide alignment and legal clarity on data ownership.
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.
How a phased CRO partnership built on ICH E6(R2) and E6(R3) principles supported a multi-indication biotech portfolio.
The second of a two-part perspective examining why clinical trial enrollment and representation outcomes are shaped long before the first patient is screened.
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.
AI can turn complex protocols into first-pass budget inputs, letting sponsors start budgeting sooner while budget builders shift from data entry to review.
