Key Considerations for Regulatory Compliant Document Storage
Compliant document storage in clinical trials demands robust systems for security, accessibility, and retention to meet privacy and regulatory standards.
Technology
Wayne State University Streamlines Compliance with Validation Services for Advarra EDC
Wayne State University simplifies FDA trial compliance by integrating Advarra EDC and Validation Services, reducing reliance on external vendors.
Top 20 Pharma Accelerates Training and Improves Compliance Across 650 Site Staff Trial
Advarra’s Study Startup solution provided training for every staff member at every global trial site, inclusive of real-time training reports, helping to ensure all 20,000 patients enrolled were treated exactly according to protocol, and enrolled seven months ahead of target
Q&A – Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
In a recent webinar, James Riddle, Shannon Roznoski, and Stuart Cotter of Advarra presented Regulatory Fine Points: Exploring 21 CFR Part
Utilizing eRegulatory Integrations to Expedite Regulatory Workflows
The processes necessary to support regulatory compliance require valuable time and resources within a clinical research institution. Regulatory tasks in particular require frequent
Inova Health System Uses Advarra eReg Workflows and Integrations to Improve Regulatory Efficiency
Learn how Inova Health System achieved a 20% increase in regulatory efficiency through Advarra eReg, optimizing operations without extra staff.
Top 10 Educational Resources of 2020
It’s safe to say 2020 has been more unpredictable than anyone could imagine. Through these unprecedented times, we have worked to provide the
Top 20 Biopharma Doubles Recruitment and Reduces Screen Failures Across 188 Sites
Top 20 Biopharma Doubles Recruitment and Reduces Screen Failures Across 188 Sites A top-20 pharmaceutical company conducted a complex Phase
New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures
What is the ROI of eLearning?
On-demand eLearning maximizes ROI by cutting classroom costs and offering accessible, effective training that aligns with modern clinical research needs.
Top 30 Biopharma Activates and Enrolls Across 164 Sites
In this case study learn how Advarra Study Startup and Advarra Enroll helped a top-30 pharmaceutical company achieve study startup milestones on time while setting their sites up for recruitment success.
Standardization and the Importance of Medical Coding Dictionaries in Clinical Trials
The data gathered in a clinical trial is often collected by many different people, including investigators and coordinators, and interpreted