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|December 3, 2019
Clinerion and Massive Bio Partner to Improve Lives of Cancer Patients
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Clinerion and Massive Bio have partnered to improve trial site selection and offer better access for cancer patients to clinical trials. Clinerion’s Patient Network Explorer queries anonymized patient data from its network of partner hospitals to deliver real-world health data insights useful for Massive Bio’s site outreach programs.
To learn more about their partnership, click
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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.
In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains why combining analog trial performance data with real-world patient data and site-level recruitment history gives sponsors a far more honest picture of whether their enrollment assumptions are actually achievable.
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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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