How Paper and Electronic Source Data Meet ALCOA-C Principles
According to the FDA, data should meet certain fundamental elements of quality (ALCOA), whether they’re recorded on paper or electronically.
Data Management
Beginner’s Guide to 21 CFR Part 11 Compliance
Ensuring 21 CFR Part 11 compliance in research software protects data integrity, security, and audit trails, essential for meeting FDA electronic documentation standards.
5 Questions to Ask Your Sponsor for DCT Implementation
The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. In
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites and sponsors ensure secure, organized trial records.
Q&A: Stepwise Implementation of a Clinical Quality Management System
Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. Q: How
The ROI of eRegulatory and eIRB Integration
Integrating eRegulatory and eIRB systems streamlines document management, enhances compliance, and delivers significant ROI through time and cost savings per protocol.
The Powerful Potential of Open Collaboration
Advarra’s Site-Sponsor Consortium emphasizes shared standards and transparent dialogue, paving the way for scalable, collaborative research advancements.
Reuniting and Reconnecting at the 2022 Onsemble Conference
Throughout the day on Tuesday, March 29, clinical research professionals arrived at the Westin Savannah Harbor Golf Resort & Spa
Addressing Research Technology Challenges to Gain Sponsor Buy-in
At Advarra, we are passionate about enabling the industry to become more site-centric. To achieve this, it is especially important
Considerations for IRB Review: Artificial Intelligence & Machine Learning
Artificial intelligence in clinical research is expanding rapidly, bringing both excitement and ethical challenges. How can IRBs ensure responsible oversight?
DMC vs EAC: What’s the Difference?
Clinical research oversight relies on both DMCs for big-picture data review and EACs for detailed event assessments. Learn how each committee enhances trial safety.