
Metrics & Benchmarks
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FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines

Benchmarking Study Finds Clinical Trial Performance Is Shaped by Operating Model Design, Not Sourcing Strategy

Operationalizing the Patient Voice: Converging U.S., EU, and UK Requirements and the Role of Real-World Patient-Reported Data

The Human Side of Clinical Trials: How Measuring Readiness at Training Predicts Trial Risk Before It Shows Up in the Data

How Clinical Teams Can Build Real Trust With Patient Advocacy Organizations

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In today's ACT Brief, we examine what families with rare epilepsy teach about trial feasibility, how preclinical CRO partnerships are evolving beyond transactional services, and why cortisol dysregulation limits GLP-1 effectiveness in diabetes.

As the life sciences industry continues to evolve, the ability to effectively manage and leverage preclinical CRO partnerships is set to become a defining characteristic of successful biopharma companies.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, shares what she has learned firsthand from families living with Dravet syndrome and CDKL5 deficiency disorder about what makes trial participation possible—and what makes it not.

In today's ACT Brief, we examine how shifting patient engagement to endpoint selection improves trial data quality, why execution infrastructure must precede AI deployment, and addressing missing baseline data in real-world oncology research.

Clinical trials have spent decades perfecting data capture, but the execution layer underneath it, including decision workflows, data collection design, and lab connectivity, remains fragmented in ways that limit what AI can realistically deliver and that quietly compromise the scientific validity of the data itself.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, describes how shifting patient engagement from protocol review to endpoint selection transforms both the quality of trial data and the experience of participation.

In today's ACT Brief, we examine why seizure reduction misses what families want from epilepsy trials, how lab coordination requires connecting data to intent, and why healthcare needs orchestration rather than more tools.

True lab orchestration isn't about coordinating instruments, it's about connecting scientific intent, data, and decisions across the entire research lifecycle.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, explains why the full burden of developmental and epileptic encephalopathies extends far beyond clinical symptoms—and why endpoints must reflect what families are actually hoping for.

In today's ACT Brief, we examine genuine patient partnership in trial design, how AI enables informed recruitment while preserving clinician relationships, and moving patient engagement beyond performative gestures.

In this Q&A, John Worden, chief commercial officer at Javara, discusses why clinical trial recruitment has remained stubbornly one-size-fits-all, how AI can identify patients at scale without displacing the clinician relationships that drive trust, and what care-integrated research engagement needs to look like for health systems, sponsors, and sites.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, explains why genuine patient partnership begins before the protocol is written—and what it looks like when patients and caregivers tell you a trial was designed with them in mind.

In today's ACT Brief, we examine why black-box AI fails in clinical trials, how participant understanding drives engagement more than gamification, and FDA permanent leadership appointments prioritizing regulatory predictability.

Participant engagement depends more on clarity and understanding than on gamification or incentives, requiring engagement embedded into trial workflows as a core design component rather than a peripheral consideration

Beyond Compliance: NetraMark's Joseph Geraci, PhD, on Making AI-Driven Patient Subgroups Explainable
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joseph Geraci, PhD, co-founder and chief scientific and technical officer at NetraMark, about why explainable AI, not black-box prediction, is needed to reveal clinically meaningful patient subgroups in regulated drug development.























