Tools for Clinical Trials Professionals
Software provides complete visibility into the regulatory submission process
Octagon Research Solutions, Inc. (Wayne, PA) recently announced an update to its enterprise submission process management solution. Viewpoint 3.6 streamlines the regulatory submission process by affording visibility into the planning and management of the drug submission process and allows users to track, manage, and compile any type of regulatory application.
Viewpoint 3.6 Resource Estimator, Reviewer, and Regulatory Dashboard have been upgraded to provide enhanced workflow estimation, collaboration, and project tracking across the submission life cycle. The new Web-based Reviewer allows content contributors to view and validate their documents in the context of a submission. This, Octagon says, lessens the possibility that clinical trial professionals will miss a submission date or file an incomplete or noncompliant eCTD submission.
ViewPoint 3.6
Octagon Research Solutions, (610) 535-6500, www.octagonresearch.com
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.