In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explains why execution failures surface where they're visible but ...
In today's ACT Brief, we examine where sponsor capability gaps accumulate in protocol execution, how partnerships are ...
In today's ACT Brief, we examine how early assumptions govern development outcomes, why single pivotal trials require ...
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, ...
In today's ACT Brief, we examine the FDA's paused real-time complete response letter release policy, why programmatic patient ...
In today's ACT Brief, we examine how FDA's single pivotal trial shift raises recruitment and retention stakes, why FSP should ...
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 local-first approaches can redesign clinical trial communication, quantitative evidence on risk-based quality management returns, and FDA approval of an oral ...
A citizen petition from an undisclosed sponsor challenged CRL disclosure processes, emphasizing inadequate company participation and incomplete redaction of confidential commercial information, citing ...
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 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 ...
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