In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution ...
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 ...
In today's ACT Brief, we examine how early assumptions govern development outcomes, why single pivotal trials require ...
In today's ACT Brief, we examine the FDA's paused real-time complete response letter release policy, why programmatic patient ...
Functional unblinding is a central threat to validity; alternative controls, central blinded raters, blinding/expectancy questionnaires, and robust concordant endpoints are recommended to mitigate ...
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 ...
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.
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 ...
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 ...
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 ...
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