In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.
|Articles|April 26, 2019
Bloqcube and NTT DATA Partner to Deliver Blockchain-Driven Management Solutions
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BloqCube and NTT DATA have announced an alliance to benefit the healthcare and life sciences industry by delivering blockchain-driven clinical trial management. BloqCube will benefit from NTT DATA’s experience in accelerating value-based healthcare, maximizing efficiency and delivering flexible solutions to achieve accuracy and customer satisfaction.
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RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.
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In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.
Sponsor oversight of outsourced CRO work is often robust in practice but fails inspection because oversight decisions are fragmented across systems and lack an audit trail, requiring sponsors to document oversight as a connected operating system with clear decision records, escalation pathways, and issue resolution from start to finish.
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