A look at the lessons learned from one platform approach to study enrollment tracking—and the wider quest for accountability in achieving diversity and inclusion goals.
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 this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explains why the belief that outsourcing execution transfers ...
In today's ACT Brief, we examine how programmatic recruitment requires portfolio funding and behavioral readiness integration, why clinical R&D modernization stalls without systems-level thinking, and ...
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 ...
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 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 the FDA's paused real-time complete response letter release policy, why programmatic patient ...
As clinical development grows increasingly complex and talent markets remain constrained, sponsors must evolve beyond binary outsourcing decisions to embrace a configurable functional service provider ...
Trial registrations doubled from 2004 to 2025, with investigator-initiated/non-industry growth outpacing Industry, and a transient 2020–2021 surge attributable to ...
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