In today's ACT Brief, we examine how sustainability is shifting from compliance to a procurement driver, what infrastructure gaps remain in FDA's real-time pilot model, and regulatory guidance targeting unnecessarily restrictive cancer trial criteria.
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.
In today's ACT Brief, we examine how data standardization must precede real-time monitoring deployment, why contracts cannot transfer sponsor oversight responsibility, and a strategic acquisition broadening immunology development.
In today's ACT Brief, we examine the data collection-to-analysis gap undermining continuous trial monitoring, why AI agents require foundational workflow infrastructure, and FDA approval of a novel ADHD treatment.
In today's ACT Brief, we examine how inspection readiness must accumulate rather than assemble, why AI initiatives stall without disciplined governance, and what US clinical trials need beyond isolated initiatives.
In today's ACT Brief, we examine why execution failures originate upstream despite surfacing downstream, how European health data frameworks transform CRO roles, and why US trial competitiveness varies by development phase.
In today's ACT Brief, we examine where sponsor capability gaps accumulate in protocol execution, how partnerships are embedding trials in community settings, and whether Project Trialblazer can compete with faster international pathways.
In today's ACT Brief, we examine how early assumptions govern development outcomes, why single pivotal trials require portfolio recruitment with integrated technology, and how risk frameworks must embed quality into design from the start.
In today's ACT Brief, we examine how outsourcing transfers accountability in sponsor organizations, why biomarker strategy requires understanding tumor biology beyond single targets, and FDA clearance for a novel sciatica treatment.
In today's ACT Brief, we examine how programmatic recruitment requires portfolio funding and behavioral readiness integration, why clinical R&D modernization stalls without systems-level thinking, and FDA's traditional approval of a kidney function-preserving therapy.
In today's ACT Brief, we examine how local-first approaches can redesign clinical trial communication, quantitative evidence on risk-based quality management returns, and FDA approval of an oral cholesterol-lowering therapy.
In today's ACT Brief, we examine CRO success through program-level partnership, FDA guidance addressing psychedelic trial design challenges, and approval of a comprehensive cancer pathway inhibitor.
In today's ACT Brief, we examine how organizational silos block programmatic recruitment strategies, why regulatory collaboration on selective safety data enables scalability, and FDA approval of an at-home Alzheimer's therapy option.
In today's ACT Brief, we examine how sponsors can shift to portfolio-level recruitment strategies, why real-time burden sampling captures operational friction before it becomes risk, and FDA approval of a platinum-free bladder cancer combination.
In today's ACT Brief, we examine the FDA's paused real-time complete response letter release policy, why programmatic patient engagement is replacing protocol-centric recruitment, and medical affairs' emerging role in bringing patient perspectives into clinical development.
In today's ACT Brief, we examine how FDA's single pivotal trial shift raises recruitment and retention stakes, why FSP should be viewed as a configurable continuum rather than binary choice, and a new pegfilgrastim biosimilar completing a major G-CSF portfolio.
In today's ACT Brief, we examine AI-enabled systems medicine connecting fragmented clinical data, how behavioral readiness and trust drive enrollment more than eligibility criteria, and scaling concentrated AI strategy across a global pharmaceutical enterprise.
In today's ACT Brief, we examine how selective safety data collection could ease operational burden and address investigator shortages, why site-specific technology limits AI adoption, and how regulatory pressure and patent cliffs are reshaping R&D investment strategy.
In today's ACT Brief, we examine regulatory partnerships debunking pragmatic trial concerns, how ePRO protocols create informal patient exclusions, and why system design—not patient behavior—drives disengagement.
In today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol failures occur during operational transition, and congressional investigation into pharmaceutical company trials in China.
In today's ACT Brief, we examine a major trial retraction and regulatory action against a rare disease drug, regulatory scenarios for selective safety data collection, and FDA's domestic manufacturing incentive program.
In today's ACT Brief, we examine what the FDA's real-time oversight initiative demands of sponsors, why clinical data security must be designed in rather than layered on, and how AI is reshaping CDMO workflows and asset value.
In today's ACT Brief, we recap key themes from DIA 2026 on operational priorities and regulatory shifts, examine infrastructure gaps in continuous data review, and report on EMA support for a new BTK inhibitor strategy.
In today's ACT Brief, we examine integrating site and sponsor data systems, a high-profile trial retraction over integrity concerns, and a new first-line breast cancer treatment.
In today's ACT Brief, we examine regulatory uncertainty and 2026 breakthroughs shaping clinical research, reimagining CRO contracting models for financial transparency, and Eli Lilly's acquisition strategy.
In today's ACT Brief, we examine HHS coordinated effort to restore US clinical research leadership, two decades of rising protocol complexity, and data architecture frameworks for AI sustainability.
In today's ACT Brief, we examine a major CRO-tech partnership scaling agentic AI, operational challenges sites face with decentralized trials, and AI-driven CNS drug discovery collaboration.
In today's ACT Brief, we examine mixed FSP models as strategic agility tools, key themes from the 2026 DIA Global Annual Meeting, and federated AI expanding oncology research.
In today's ACT Brief, we examine real-time evidence generation priorities, automating protocol digitization, and fit-for-purpose decentralized trial deployment.
In today's ACT Brief, we examine quantified returns on RBQM implementation, why allowing sponsors to control AI governance builds adoption, and how basket trials reshape rare pediatric oncology development.
