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Lab Orchestration Is Not What You Think It Is

Why Seizure Counts Alone Can't Define Success in Epilepsy Trials

ACT Brief: Patient Voice in Protocol Design, AI-Informed Recruitment Workflows, and Engagement Maturity Beyond Performative

Recruitment in the Age of AI: Q&A with John Worden, Javara

What It Actually Means to Embed the Patient Voice in Trial Design

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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.

In today's ACT Brief, we examine how regulatory guidance and financial evidence enable RBQM adoption, why site payment performance remains a competitive differentiator, and a collaboration advancing an inhaled approach to cystic fibrosis.

In this Q&A, Patrick Mizer, chief technology officer at Ledger Run, discusses how payment reliability has become a competitive differentiator in site selection, why decades of disconnected workflows have made payment inconsistency a structural problem, and where AI is delivering real value in the high-friction parts of clinical trial payments.

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain how ICH E6(R3) and new empirical evidence of RBQM's net financial impact give sponsors the tools they need to build the multi-functional buy-in required for successful adoption—and why RBQM only delivers full value when it replaces, not supplements, traditional monitoring.

In today's ACT Brief, we examine value hidden in the RBQM financial model, why rare disease research leads on genuine patient partnership, and how safety concerns shape IBD treatment decisions despite clinical efficacy.

Patient-centricity remains largely consultative in most clinical research, yet rare disease communities demonstrate that genuine partnership from protocol inception improves feasibility, reduces unnecessary burden, and identifies outcomes that matter to patients themselves.

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD discuss what the RBQM financial model left out—reduced rework, improved data integrity, and inspection readiness—and why those excluded factors could represent even greater value than what was modeled.

In today's ACT Brief, we examine why time savings dominates the financial case for RBQM investment, how the FDA is strengthening inspection access and data integrity review, and how data governance models shape real-world evidence quality.

Senior FDA leaders outline concrete steps to strengthen inspection coverage and data integrity review as the globalization of clinical research strains the agency's oversight capacity.

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain why time savings dominates the eNPV model for RBQM—and what that means for how sponsors should frame the internal case for investment.

In today's ACT Brief, we examine why many trial failures trace to human readiness gaps rather than process design alone, how CRO consolidation expands early-phase capacity, and how AI-enabled patient matching is reshaping recruitment economics.

As sponsors push for faster, more representative studies, AI-enabled matching and EHR integration are emerging as operational levers, but bias, explainability, and governance will determine whether the technology scales.

The all-cash transaction adds a good laboratory practice-compliant bioanalytical laboratory, a 200-bed clinical pharmacology unit, and a biospecimen storage facility to Fortrea's early-phase development network.






















