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In this Q&A, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discusses the collaborative work underway with FDA and CTTI to explore selective safety data collection as a model for de-risking trial design, reducing site and patient burden, and scaling pragmatic trial approaches across the industry.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, identifies organizational silos, siloed budgets, and a study-centric mindset as the biggest barriers to shifting from study-by-study to programmatic recruitment—and explains what it actually takes to map a program that sponsors might not see at first.

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.

Experience sampling captures real-time signals of site burden and operational friction at the moment they occur, providing earlier and more actionable insight than retrospective assessments and revealing workarounds before they compound into protocol deviations.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, outlines the organizational, budgetary, and technological changes sponsors need to make to move from study-by-study recruitment to a portfolio-level approach that keeps patients engaged across a therapeutic area.

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.

The agency's complete response letter transparency initiative has been on hold since April following a pharma industry legal challenge, even as the FDA moves to codify the practice through formal rulemaking.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, explains why the industry's protocol-centric recruitment model has persisted so long and what a shift toward programmatic, relationship-driven patient engagement actually looks like in practice.

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

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, explains how the FDA's shift toward single pivotal trials is raising the stakes for sponsors on recruitment quality, feasibility precision, diversity, and retention—and why sponsors now say they get one shot to get it right.

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.

Eligibility criteria alone rarely predict enrollment, which depends more on trust, hope, and fear, requiring relationship-based community engagement paired with behavioral readiness assessments rather than transactional outreach.

AI-enabled systems medicine could influence which populations are selected for trials, how biomarkers are validated, how products are positioned, how evidence is generated after launch, and how value is demonstrated to payers.

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 this Q&A, Liz Beatty, co-founder and chief strategy officer at Inato, discusses how real-time patient data is reducing non-enrolling sites, why sponsor-specific technology remains the biggest barrier to adoption, and what a shift toward cross-asset site partnerships could mean for enrollment efficiency.

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.

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 this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discusses how CTTI tabletop exercises are myth-busting perceived risk and why true progress requires partnership across regulators, sponsors, providers, and patients.

When clinical trial teams screen for "tech-savvy, engaged" participants, they're often running a second, unwritten eligibility criterion that systematically excludes the populations the study drug is actually meant to treat.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, explains why scaling pragmatic and decentralized trial approaches, not just piloting them once, is where the real reduction in cost and burden happens.

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.

Protocol assumptions about patients, visit schedules, timelines, and vendors are rarely tested against operational reality until startup, but early engagement of experienced execution strategists can identify and mitigate feasibility gaps before commitments harden into expensive course corrections.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, breaks down CTTI research showing 50 to 75% reductions in visits and assessments using selective safety data collection, and why mature assets make this approach safe to use.

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 this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, explains how four jointly developed regulatory scenarios give sponsors a blueprint for adopting selective safety data collection with greater confidence and stronger agency alignment.

Regulators on both sides of the Atlantic have taken action against Tavneos after an FDA investigation found patient outcome data was altered and trial personnel were unblinded during the pivotal study that supported the drug's approval.

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.

The FDA's launch of real-time clinical trial proof-of-concept studies signals a fundamental shift in regulatory oversight, one that most sponsors are not yet equipped to meet and that demands urgent investment in unified data infrastructure, quality-by-design practices, and protocol digitization.