New FDA guidance signals a major shift for CAR-T development, calling for randomized trials with standard-of-care control groups and clear evidence of superiority over existing therapies, while ...

In today’s ACT Brief, we explore how stronger vendor–sponsor governance is speeding eCOA study startup, hear from AMR ...

Gain insights into the operational challenges facing clinical research sites today, learn what sponsors and CROs can do to ...

Strong relational governance between technology vendors and sponsor–CRO teams is becoming a critical foundation for eCOA ...

In today’s ACT Brief, we look at how AI and in-silico methods are reshaping drug repurposing, why staggered ICH GCP rollouts ...

ACT: As new ICH GCP guidelines roll out, how are sponsors balancing the drive for innovation—especially in areas like CAR-T ...

AI-driven discovery, EHR-based real-world evidence, and synthetic patient modeling are rapidly reshaping drug repurposing, reducing development timelines, expanding therapeutic applications, and ...

In today’s ACT Brief, we look at what’s fueling rapid growth in CNS and autoimmune research, why former FDA leaders are ...

Chen: Yes, obesity is experiencing accelerated growth over the last couple of years. According to our sister product Evaluate ...

Investigate how sponsors are responding to rapid growth in obesity drug development, including strategies for manufacturing, supply chain optimization, dosing innovations, and combination therapies to ...

In their NEJM commentary, the former FDA heads stated, “We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ...