Part II Scope and Application Guidance from FDA

How clinical operations teams can close the gap between controlled trial results and real-world adoption by generating evidence in broader, more representative patient populations.

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 data from the pivotal GEMZ study show significant seizure reduction with adjunctive fenfluramine in CDKL5 Deficiency Disorder.

At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.

Updated results from the Phase II RedirecTT-1 trial show that the dual bispecific antibody regimen of Talvey and Tecvayli delivers deep, lasting responses in patients with triple-class exposed relapsed or refractory multiple myeloma and true extramedullary disease.