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 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 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 this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain how combining real-world deployment data with eNPV modeling finally made it possible to put a number on the financial value of RBQM—and why oncology was chosen as a conservative starting point.
In this video interview, Patrick Mizer, chief technology officer at Ledger Run, addresses the reality that 80% of sites operate on six months or less of cash—and explains why growing investment in agentic AI and workflow modernization signals that the industry is starting to treat payment infrastructure as the priority it deserves.
In this video interview, Patrick Mizer, chief technology officer at Ledger Run, explains how unpredictable payments erode site relationships over time—and why operational excellence in payments is becoming increasingly important to landing and retaining the best investigative sites.
In this video interview, Patrick Mizer, chief technology officer at Ledger Run, describes how agentic AI is being applied to invoice processing—one of the most labor-intensive bottlenecks in site payments—and what meaningful improvement actually looks like in practice.
In this video interview, Patrick Mizer, chief technology officer at Ledger Run, traces the fragmented contracts, outdated benchmarks, and disconnected systems behind payment inconsistency—and explains why the industry has historically accepted the complexity rather than addressed it.
In this video interview, Patrick Mizer, chief technology officer at Ledger Run, explains how the shift from competing for patients to competing for high-performing sites has made payment reliability an operational brand—and a real factor in which sponsors get prioritized.
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 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 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 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 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.
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 this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, reframes what "leaner" really means in practice—not cutting corners, but deploying fractional teams and strategic partners to reach inflection points faster on limited capital.
In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, makes the case that commercial strategy must now inform clinical development from the earliest stages—and what that means for indication selection, trial design, and endpoint choices.
In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, identifies the funding gap and indication selection trade-offs as the most consequential risks facing early-stage programs today—and why great assets still fall behind when those decisions go wrong.
In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, explains how declining NIH funding, late-stage pharma acquisition strategies, and global operating pressures are forcing sponsors to move faster and more capital-efficiently toward clinical inflection points.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, outlines a gradual, win-driven strategy for making real-time monitoring stick—starting in early phases and building toward pivotal trials with the right technology partners and a network effect that scales.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, makes the case that scaling real-time data review requires an ecosystem approach—bringing regulators, sponsors, CROs, and technology vendors together in a shared learning environment rather than letting progress remain siloed.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, explains why the FDA's real-time clinical trial pilot was promising but not yet scale ready—and what technology infrastructure needs to be in place for the model to work broadly.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, breaks down the standardization and mapping work that must happen before streaming data can be analyzed meaningfully—and how AI is beginning to make that process fast enough to enable real-time monitoring at scale.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, explains why the gap between data collection and analysis-ready data undermines the promise of continuous trial monitoring and what it will take to close it.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, describes what it means to accumulate inspection readiness rather than assemble it—and why the story regulators reconstruct is determined long before an inspection is announced.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explains why execution failures surface where they're visible but originate where conditions were set—and why clinical operations leaders too often inherit problems they had no hand in creating.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, identifies where the most consequential capability gaps accumulate—from protocol-to-execution bridging to how sponsor oversight roles are structured and staffed.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, makes the case that the assumptions accumulated at the moment of a product development decision govern everything that follows—and why deferring that work doesn't save time, it just makes it more expensive to fix.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explains why the belief that outsourcing execution transfers accountability is the most consequential and least examined gap in how sponsor organizations are structured.
In this video interview, Gaynor Anders, chief delivery officer at Trialbee, makes the case that success for CROs in a program-level recruitment model comes down to true partnership, shared data visibility, and a collective commitment to moving patients all the way through the funnel.
