eShowcase: Company Introduces and Validated Products
EDC 4.1 System Goes Through Paces; Document Management Announced
EDC 4.1 System Goes Through Paces; Document Management Announced
Octagon Research Solutions (Wayne, PA) recently completed its 140-point user requirements validation of its ViewPoint FUSE EDC 4.1 platform. These requirements were related to 21 CFR Part 11 compliance; management of sites, subjects, and case books; data entry and review processes; edit checks; and manual- and system-generated queries.
The company also announced its ViewPoint for Document Management, a solution combining document management, authoring templates, document standards, and expert guidance. It is offered in two models: a traditional install/implementation and a new hosted model that eliminates installation, hardware, and validation costs in favor of a direct connection to Octagon resources.
Octagon Research Solutions, (610) 535-6500, www.octagonresearch.com
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
CAHtalyst Trial Shows Crenessity Sustains Efficacy in Classic Congenital Adrenal Hyperplasia
July 14th 2025Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
