Medidata has launched Medidata Risk Management, the latest addition to its Risk-Based Quality Management (RBQM) suite, a holistic group of solutions aiming to simplify the adoption of proactive clinical operations oversight activities. These include centralized monitoring, reduced source data verification and source data review, remote source document review, and implementation of decentralized trial activities.
Built on the Medidata Clinical Cloud and fully integrated with Medidata’s centralized monitoring tool, Medidata Detect, Medidata Risk Management supports sponsors and contract research organizations (CROs) as they identify critical data and processes, associated risks, and implement mitigation strategies as defined within ICH E6 (R2). With recent updates to Medidata Detect, study teams can also compare site differences across all participants to uncover trends or anomalies and determine whether there are discrepancies in data collection or integrity to be investigated.
For more information, click 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.