ACT Brief: Trial Representation and Design, CRO Revenue Recognition Risks, and Real-Time FDA Data Review

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

• In part three of her conversation with Rebecca Johnson, PhD, Adrelia Allen described how improving representation has changed trial design and site selection at Merck. Allen identified the hardest remaining barriers and outlined what the industry will need to sustain meaningful progress over the next five years.
• In a new contributed article, CRO revenue recognition under ASC 606 faces significant risks from misidentified performance obligations, inaccurate progress measurement, and variable consideration estimation errors. Operations plays a critical role in stabilizing revenue by improving predictability in site activation, enrollment curves, and data-cleaning timelines, with technology-enabled controls and cross-functional alignment essential to reducing margin volatility and audit exposure.
• In a new interview from Pharmaceutical Executive, Dr. Richard Graham, chairman of Tru Technologies, discussed FDA's pilot program for real-time clinical data review. The initiative aims to eliminate delays between site data collection and FDA signal detection by having data flow from sites to sponsor and FDA in parallel, removing inefficiencies in the traditional analysis and reporting cycle.

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