Integrating Sponsor and CRO System & Business Processes

Interim Phase IIb data from the SURVIVE trial support continued evaluation of SurVaxM, a survivin-targeting vaccine, in newly diagnosed glioblastoma and other tumor types.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

New Phase II data presented at ENDO 2025 highlight avexitide’s potential to significantly reduce severe hypoglycemic events in patients with post-bariatric hypoglycemia, with Phase III results expected in 2026.

Results from a retrospective study found that Amtagvi (lifileucel) achieved a 48.8% objective response rate in patients with advanced melanoma who had previously received immune checkpoint inhibitors.

In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.