Technology
Beginner’s Guide to 21 CFR Part 11 Compliance
FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.
Regulatory and Ethical Considerations for eConsent in Research
If any part of your informed consent process involves an electronic component, you’re conducting eConsent.
Advarra Trend Report: Current State of Trial Opportunity and Selection
Insights into the site selection process and the information sites provide as part of site feasibility questionnaire completion.
Enhancing Research Conduct Using eConsent
The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.
Bridging the Gap: A Standardized Approach to Clinical Trial Document Management
Representatives from the Advarra Site-Sponsor Consortium will discuss a standards-based integration and automation of research technology.
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools
Advarra Launches Cloud-Based Secure Document Exchange to Accelerate Study Startup
Solution provides end-to-end integration and automated, seamless exchange of research documents between sites, sponsors, and CROs
Top Barriers to Participation in Clinical Trials
Understanding the factors that influence the decision to participate in a study helps research professionals diagnose enrollment problems.
Patient Recruitment and Enrollment in Clinical Trials
Learn more about patient recruitment and enrollment: how they find out about clinical trials and the reasons they participate.
A Checklist for Optimizing Clinical Trial Study Startup Activities
This checklist outlines key milestones and considerations for sites and sponsors in the clinical trial study startup process.
Best Practices in Pre-Screening Includes Use of Technology
Explore the benefits of pre-screening potential participants before they move on to the informed consent process.
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