System treats compliance as a single, repeatable process to ensure organizational quality
System treats compliance as a single, repeatable process to ensure organizational quality
QUMAS (Florham Park, NJ) has released an end-to-end closed-loop compliance solution for life science companies. The QUMAS Compliance Closed-Loop Process™, which the company says is the first product of its kind in the industry, automates the tracking and management of compliance, business, and quality issues enterprise-wide.
The solution integrates various tasks with other processes critical to regulatory compliance. Rather than treating compliance as a series of silos that vary with department and/or product lifecycle stage, the Compliance Closed-Loop Process treats it as a single procedure.
The QUMAS approach automates the generation of internal or external complaints, product nonconformances, deviations, audits, investigations, and all other compliance actions. The tool captures, records, routes, and verifies completion and approvals while auditing each step in a sponsor's quality management process.
QUMAS, (800) 577-1545, www.qumas.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.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
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.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.