sIRB Review for Multicenter Research: A Guide for Institutions
Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...
Checklist to Reduce Burden on Sites and Patients
Review a list of considerations for site-sponsor tasks to streamline startup, reduce redundancy, and refine technology choices for effective partnerships.
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
How to Improve Your Site Compliance
Many clinical trial sites face challenges to stay compliant on a study. It is important for sites to adhere to the myriad of requirements that constitute Good Clinical Practices (GCP).
Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance
Monitor four critical metrics across your sites to prevent persistent challenges to clinical trials
How Sponsors and Sites Work Together to Improve Protocol Compliance
As trials continue to increase in complexities, sites and sponsors must work together to minimize deviations and cause for FDA findings.
Clinical Trial Startup: Insights from the Industry
Clinical research professionals provide relevant insights into challenges and barriers impeding study start up.
Best Practices for IRB Review of DCTs: Expert Perspectives
Leverage best practices for IRB review of decentralized trial elements sourced from research community experts.
What is a Data Monitoring Committee?
In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.
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.
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.
Unlocking Global Potential: Partnering Across Varying Sites in Study Startup
Join us as Advarra experts outline how sponsor organizations can work with various site types across trials and adapt their resources accordingly.