Data Management
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
Tracking an Effective QMS: From Discovery Through Post Study
Explore strategies for sponsors and CROs for implementing an enterprise phased QMS assessment, and address deficiencies in compliance and implement corrective actions.
Understanding Various Site Use Cases for eSource and EDC
Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance.
Advantages and Considerations for an eRegulatory Implementation
Gain an understanding of what an eReg system is and the features available to streamline clinical trial regulatory management.
4 Modernized Functions Every Sponsor Needs for Study Startup
This white paper outlines four technology capabilities sponsors need to expedite the study startup process.
Key Efficiencies Driven by a Clinical Trial Management System
Find out how sites can get the most value from their clinical trial management system (CTMS) to streamline operations.
Data on the go: Mobile Application Considerations for Clinical Trials and Beyond
Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.
University of Nebraska Medical Center Streamlines Regulatory Management and Accelerates Study Startup with Advarra eReg
Learn how Advarra eReg helps UNMC support remote monitoring and how eReg helped address prevalent challenges in clinical research.
Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices
Discover how to protect participant privacy in mobile-app-based clinical research. Learn about risks and what IRBs need to consider in protocol review.
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.
NIH 2023 Data Management and Sharing Policy: What you Need to Know
Optimizing Your Data Management Plan: Best Practices for Biomedical Research under the NIH Data Sharing Policy
Understanding how to Build and Leverage a DSMB Statistical Plan
Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.