eShowcase: ComplianceWire
Enhancements to workplace planning tool include "what if" scenario capability
Enhancements to workplace planning tool include "what if" scenario capability
EduNeering (Princeton, NJ) has added several functionalities to ComplianceWire, its knowledge management system designed for FDA-regulated businesses. Key enhancements include a workplace planning tool researchers can use to create "what if" scenarios for determining job qualifications, planning for future growth, vacation scheduling, and cross training.
Other new capabilities include electronic sign-in for instructor-lead courses, eliminating paper-based systems, and providing a layer of authentication to monitor attendance and streamline recordkeeping. The new User Group format allows administrators to organize and manage employee qualifications, career goals, and other role-based activities. They can then suggest knowledge criteria and curricula based on employee qualifications.
EduNeering, (609) 627-5300, www.eduneering.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.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
