Securing the Integrity of Investigator-Owned Audit Trail Data… It’s Not Just for Sponsors Anymore

A pivotal trial that missed its primary endpoint became the basis for a successful redesign after the team used the data to define the high-risk patients most likely to benefit, showing that setbacks can strengthen development when organizations interrogate the evidence rather than abandon it.

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, outlines why faster recruitment, local data requirements for registration, and lower costs make APAC attractive for global Phase III programs.

In today’s ACT Brief, we examine how China’s trial startup timelines compare with those in the US and Europe, whether AI-drafted clinical study reports speed drug development, and how Bimzelx compared with Skyrizi in psoriatic arthritis.

AI can draft a CSR in minutes, but the report only reflects evidence that has already converged, so faster drafting shifts the bottleneck to upstream reconciliation, database-lock readiness, and human accountability rather than shortening the trial itself.

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, details how NMPA reforms, parallel reviews, and expanded reviewer capacity brought China’s startup timelines in line with the US and Europe, and could shorten them further.

In today’s ACT Brief, we examine why APAC inspection findings mirror those in the US and Europe, how key risk indicators should be read together, and how FDA granted accelerated approval to a subcutaneous antibody therapy for recurrent head and neck cancer.

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how FDA inspection findings at APAC sites compare with those in the US and Europe, and why the common issues, such as informed consent versioning, are not unique to the region.

In today’s ACT Brief, we examine why outdated views of Asia Pacific trial sites persist, how community access gaps reflect both patient costs and site infrastructure, and how VeonGen has aligned with the FDA on a pivotal gene therapy trial design.