Commonwealth Informatics Launches Big Data Offering

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

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.

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.

In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.

The Phase III BASIS trial found that once-weekly subcutaneous Hympavzi reduced treated bleed rates by 93% in patients with hemophilia A or B with inhibitors, offering a promising new prophylactic option for a population with limited therapeutic choices.