BostonGene has entered a new collaboration with AstraZeneca to apply its foundation AI model to oncology drug development, aiming to improve early trial decision-making around safety, efficacy, and ...

Securing comparator drugs in the EU is a complex process shaped by availability constraints, regulatory expectations, and competitive market behavior. But if we have the right planning, strong ...

In today’s ACT Brief, we examine why representative enrollment remains a barrier in US cancer trials, review Johnson & ...

The JASMINE trial showed nipocalimab's efficacy in SLE, meeting primary and secondary endpoints, including steroid sparing ...

So having a representative population is really important. One part of that is being able to enroll more patients in the ...

In today’s ACT Brief, we explore how site initiation can be leveraged to improve early trial performance through demonstrated ...

By leveraging the Fresh Start Effect at site initiation and shifting from passive training to demonstrated readiness, ...

In today’s ACT Brief, we examine persistent barriers limiting cancer trial participation and emerging approaches to address ...

Understand which barriers to cancer trial participation remain most difficult to overcome, including geography and trial ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

Unclear boundaries between investigator-controlled and sponsor-managed data in IRT systems are creating avoidable compliance risk, particularly around investigational product inventory and quality ...

In a new ACT video interview, Shanthi Sivendran, MD, MSCR, MBA, senior vice president for cancer care support at the American ...