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In today's ACT Brief, we examine why data quality is the ceiling for all other trial modernization efforts, how CRAs are shifting from compliance monitors to data-enabled partners, and recognition of five rising industry leaders shaping pharma innovation.

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 today's ACT Brief, we examine why protocol training completion doesn't ensure site execution readiness, how AI clinical monitoring drives measurable financial returns, and structural compliance failures behind rising FDA warning letters.

New eNPV modeling applied to operational data from an AI clinical monitoring agent finds ROI multiples as high as 82x, with time savings and monitoring cost reductions identified as the primary value drivers.

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 today's ACT Brief, we examine new strategies for breaking efficacy plateaus in IBD through combination approaches, why clinical research teams lose talent at the early-career stage, and how FDA's Priority Review Voucher program is reshaping rare disease capital flows.

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.

AbbVie’s head of immunology clinical development, Kori Wallace, MD, PhD, discusses how combination therapies, translational science, and emerging immune-reset approaches could usher in a new era of treatment for inflammatory bowel disease and other autoimmune conditions.

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.

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 today's ACT Brief, we examine how biotech reaches inflection points on limited capital, how the FDA is restructuring early clinical development to reclaim US competitive standing, and a new combination therapy for treatment-resistant melanoma.

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.