CRO
QMS for Artificial Intelligence
Discover how Advarra's ReadyQMS program transformed a biotech startup's quality and compliance, driving success.
Unlocking Study Activation: 2023 Study Activation Report
Access the survey report now for current perspectives on study startup activities impacted by rapidly evolving technology and tools.
What Happens When a Study Fails to Meet Its Recruitment Targets?
Explore IRB considerations for overcoming study enrollment barriers while ensuring risks to participants are appropriately minimized.
Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
A robust corrective and preventive action (CAPA) stands as a critical tool for proactively addressing deviations in clinical research.
Best Practices for IRB Review of DCTs: Expert Perspectives
Leverage best practices for IRB review of decentralized trial elements sourced from research community experts.
Advarra Implements Global Clinical Quality Assessment and Corrective Action Initiatives
Discover how Advarra helped a mid-size R&D device company improve global GCPs and clinical trial quality with tailored assessment and corrective action strategies.
What is a Data Monitoring Committee?
In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.
GxP Best Practices for Safer, Smarter, Faster Clinical Research
Uncover key regulations and insights regarding GxP in pharmaceuticals, medical devices, and clinical research.
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.
Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
As FDA CBER prepares to launch Operation Warp Speed for Rare Diseases, there is an expected rapid growth in gene therapy.
How Centralized IBC Review Can Benefit Gene Therapy Research
Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.
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.
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