Regulatory

A new survey of 37 US biotechnology executives finds broad preference for conducting first-in-human trials domestically, with regulatory unpredictability and clinical holds cited as the primary drivers of overseas migration.

Clinical research associates are evolving from compliance-focused manual monitors to data-enabled strategic site partners, but organizations need analytics training, clear operating models, and active change management to make the shift stick.

From point-of-care sample collection to real-world data curation, wearable device integration, and continuous review infrastructure, data quality is not a single problem in clinical trials—it is a layered challenge that manifests differently at every stage of development and demands a different set of solutions at each one.

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joseph Kim, Chief Strategy Officer at ProofPilot, and Lauren Briggs, Chief Customer Officer at ProofPilot, about why completing training is not the same as being prepared to execute a protocol.

In this Q&A, Richard Graham, PhD, co-founder and chairman of the board at TruTechnologies, discusses why six decades of manual site-level processes continue to undermine clinical trial execution, what national initiatives like Operation TrialBlazer leave unaddressed, and why meaningful modernization has to start with data collected at the point of care.

Acting CBER director Karim Mikhail outlines the structural barriers slowing Phase I trials in the US and details how the FDA's Expedited IND Pilot is designed to address them.

Real-time AI-enabled decision-making only accelerates development when trials have coordinated operational infrastructure for randomization, supply management, and workflows capable of responding to new insights without disrupting execution or compliance.

Under-enrollment isn't news to teams running oncology trials, and the instinct is to spend more on reach. The evidence, however, says the biggest leak is something else entirely and that most recruitment budgets focus on the least valuable part of the problem.

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.

Real-world oncology data requires hybrid curation combining clinical expertise with technology to address variability in documentation, missing data, and complex concepts like lines of therapy that are often implicit rather than explicitly recorded in EHRs.

Consumer-grade wearables offer promise for reducing trial burden and improving engagement, but accuracy and reliability vary substantially by device, measurement, and population, requiring rigorous fit-for-purpose validation and careful endpoint selection before integration into regulated research.

As agentic AI, automated data harmonization, and real-time monitoring reshape clinical development, the organizations seeing meaningful results are those that have invested in unified data infrastructure and disciplined governance rather than cycling through pilots without the foundation to scale them.

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.

New documents targeting performance status, washout periods, and laboratory value thresholds aim to close the gap between patients willing to participate in oncology trials and those who actually enroll.

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.

Clinical development operates as an integrated system where dependencies persist across phases and vendors, but treating contracts as execution handoffs creates invisible oversight gaps that surface later as vendor performance problems, timeline slips, or inspection findings.

AI agents operate only within workflows, but most organizations lack unified workflow management systems, making it difficult to identify where agents should be deployed or ensure they integrate effectively across connected business processes in clinical research.

The European Health Data Space reshapes CRO operations by transitioning them from data custodians to regulated users accessing data within secure, auditable environments, enabling cross-border research but requiring substantial investment in compliance, standardization, and methodological rigor.

In this Q&A, Gaynor Anders, chief delivery officer at Trialbee, discusses how the FDA's single pivotal trial shift is raising the stakes on patient recruitment, why the study-by-study model has persisted for so long, and what program-level recruitment actually requires from sponsors in terms of infrastructure, data sharing, and organizational change.

Clinical R&D modernization stalls through incremental optimization of individual workflows, but meaningful systemic change requires leaders to visualize structural relationships, understand hidden incentives, and identify leverage points that benefit the whole system rather than parts.

As the FDA's single-trial standard raises the cost of recruitment failure and diversity expectations intensify, sponsors are under pressure to move beyond study-by-study outreach toward programmatic, relationship-based approaches that treat patient engagement as a long-term strategic capability rather than a per-study operational task.

The traditional global-to-local communication model creates fragmented content through sequential adaptation, but a local-first approach using structured data and AI-orchestrated generation can embed stakeholder terminology and preferences from the start, reducing rework while improving clarity and relevance.