Catalent Completes Expansion at Singapore Clinical Supply Facility

A blend of FSO and FSP models in the landscape of artificial intelligence can ensure CROs stay up to date with the unique demands of industry.

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.

Pimicotinib, an investigational colony stimulating factor-1 receptor inhibitor being developed by Abbisko Therapeutics and licensed by Merck KGaA, met MANEUVER’s primary endpoint of objective response rate.

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

In a post-hoc analysis from the Phase III ARANOTE trial, new results show metastatic castration-sensitive prostate cancer patients treated with Nubeqa plus ADT experienced a clinically meaningful improvement in health-related quality of life and delayed pain progression.