Medidata announced the launch of its Strategic Monitoring suite, which meets ICH E6 guidelines by motivating clinical research teams to collaborate and manage all cross-functional, risk management, and centralized data monitoring activities through end-to-end workflows. This new solution will help manage the new guidelines thus avoiding the repetitive process that was once in place.
Read the full release here.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.