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 ...

In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, identifies where the most consequential capability gaps accumulate—from ...

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 ...

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 ...

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 AI-enabled systems medicine connecting fragmented clinical data, how behavioral readiness and trust drive enrollment more than eligibility criteria, and scaling ...

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 ...