Latest News

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.

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.

Clinical data security built into system architecture from the foundation, rather than layered on afterward, reduces regulatory risk and actually accelerates research by removing manual compliance burden and improving team confidence in data integrity.