infocusaug25

August 20, 2025

CAR-T Therapies and the Elimination of REMS Requirements: What Clinical Research Sites Need to Know

The FDA has lifted REMS requirements for all approved CAR-T therapies, a move that could transform access for patients and research sites alike. What does this mean for trial participation, site activation, and the future of cell and gene therapy? Read on to see how this shift reshapes the CAR-T landscape.
August 20, 2025

More Data, Less Burden: How Sites Are Winning with EHR-to-EDC Connectivity

Data entry continues to be one of the biggest sources of burden for sites. Electronic Health Record (EHR) to Electronic Data Capture (EDC) data transfer technology is a leading example of how sponsors, sites, and vendors are collaborating as an ecosystem to reduce the data entry bottleneck in clinical trial operations.