For kidney transplant recipient Janet Handal, the recent push to phase out COVID-19 research could have a deadly outcome. In early 2021, Handal participated in a study that found almost half of organ ...

The first technology-enabled remote clinical trial was launched nearly a decade ago, and that field – now generally referred to as "decentralized clinical trials" – has been advancing and gaining ...

Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents This study reviewed all industry-sponsored phase I clinical trial protocols ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...