Welcome

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.

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.

How human-centered AI that is focused on customer, user, and employee experience can drive real transformation in clinical trials and beyond by aligning intelligent technologies with the people who use them.

Peter Ronco, CEO, Emmes, shares his long-term vision for artificial intelligence in clinical research, from making automation routine to improving drug discovery, transforming regulatory oversight, reducing animal testing, and promoting ethical, equitable data use worldwide.

Primary results from the Phase II TRANSCEND FL trial show Breyanzi (lisocabtagene maraleucel) achieved a 95.5% response rate and durable efficacy in relapsed or refractory marginal zone lymphoma, supporting its potential as a transformative CAR T-cell therapy.