EMA to Relocate to Amsterdam, The Netherlands

Using a recent survey on the adoption of AI/ML conducted by the Tufts CSDD as context, pharma leaders discussed how they are using these technologies to optimize trial execution.

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.

In our June issue, explore how clinical research is adapting to regulatory changes, AI advancements, and modernizing trial designs for improved safety and efficiency.

Balancing the emerging benefits of AI in pharmacovigilance with new responsibilities and demands from regulators in enhancing efficiency and safety.

Navigating a complex drug development landscape, sponsors must rethink their approach to risk in study design and execution.