ACT Brief: RBQM Multi-Functional Buy-In and E6(R3), Site Payment Performance and Cash Runway, and Inhaled Therapy for Cystic Fibrosis

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part four and final segment of the interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explained how ICH E6(R3) and new empirical evidence of RBQM's net financial impact give sponsors the tools they need to build the multi-functional buy-in required for successful adoption. RBQM only delivers full value when it replaces, not supplements, traditional monitoring, making governance and operating model change prerequisites to deployment.
• In a new Q&A, Patrick Mizer, chief technology officer at Ledger Run, discussed how payment reliability has become a competitive differentiator in site selection as high-performing sites gain more study opportunities than they can support. With 80% of sites operating on six months or less of cash, improving payment infrastructure is no longer optional, and agentic AI is proving effective at removing manual invoice processing that consumed 60% of customer time historically.
• Aptar Pharma and Aceso Therapeutics partnered to advance a gene therapy candidate designed to target the underlying disease mechanisms of cystic fibrosis affecting approximately 100,000 people worldwide. Nanopharm, Aptar Pharma's inhalation development services business, will lead formulation development and device assessment, applying inhalation science expertise to an early-stage asset ahead of clinical evaluation.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.