Clinical Operations & Strategy

Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.

AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.

Cell and gene therapy access expands into community care settings only when operational coordination, site readiness, and supply chain standardization become first-order priorities equivalent to manufacturing capacity, requiring standardized processes, digital integration, and distributed logistics networks.

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, about why defensible trial data depends on traceability, platform ownership, and device strategy long after a study ends.

This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.

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.

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

This pilot episode of The Human Side of Clinical Trials introduces a framework from Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., exploring why operational failures in clinical trials often trace back to gaps in human readiness rather than process design alone.

Static budgeting models and one-size-fits-all fair market value approaches create visibility gaps around inflation and true site costs, but regional frameworks, standardized costing toolkits, and accountability metrics can rebuild trust and replace defensive negotiations with transparency.

AI platforms that absorb trial data reconciliation could compress operations toward a small, accountable team.

Biomarker-informed trial enrollment appears straightforward for identifying responders and optimizing efficiency, but failures to account for demographic variation in cut-off selection, causality versus correlation, and composite biomarker complexity risk excluding viable patients and exacerbating disparities.

As trials grow more global and complex, fragmented financial systems are becoming a liability. Connecting them with AI is the next operating model for clinical trial finance.

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joel Stanley, CEO of AJNA BioSciences, about why botanical therapies need pharmaceutical-grade standardization and clinical evidence to earn physician trust and insurance coverage.

In this Q&A, Stella K. Vnook, PhD, CEO and executive chair of Kaida BioPharma and founder and CEO of Aviva Ventures, discusses how a trifecta of funding pressures is reshaping early-stage clinical development, why commercialization readiness can no longer wait until late-stage, and what a truly strategic lean development model looks like in practice.

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.

Clinical research coordinators face early burnout driven by gaps between job expectations and operational reality, inadequate mentorship structures, and fragmented technology environments that compound insufficient onboarding and deplete resources needed to sustain engagement.

In this Q&A, Elizabeth Walsh, PMP, ACRP-CP, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, discusses the persistent misconceptions about sponsor accountability, why execution gaps originate long before study startup, and what genuine inspection readiness looks like when it is built in from the outset.

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 pilot episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Paulo Limgenco, VP of business operations and ESG strategy lead at YPrime, about how sustainability is shifting from a compliance checkbox to a factor that shapes vendor selection, client trust, and long-term business value.

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.

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.

The evolving role of medical affairs in connecting patients, physicians, and evidence generation.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, looks ahead to how simplification built through selective safety data collection could ease broader trial operations and help address a shrinking investigator pool.