Medidata Link: Combining Patient-Level Clinical Trial And Real World Data

Due to challenges in obtaining, integrating, and handling sensitive data, clinical trial data (CTD) and real world data (RWD) have mostly existed in disparate silos. These silos leave sponsors without a full view of the patient’s journey outside of the confines of their clinical trial, resulting in significant delays in generating data such as safety and effectiveness evidence. The industry has taken notice, and with new legislation and regulatory guidance, sponsors are increasingly realizing the impact that RWD will have in filling key evidence gaps.