Reporting Requirements
GxP Compliance in Clinical Research
This white paper walks through key GxP principles and regulatory requirements and gives a real-world case study.
Leading CRO Accelerates Startup with Integrated, Centralized IRB/IBC Reviews
Advarra’s integrated central IRB and IBC review services helped Parexel accelerate the delivery of life-saving and innovative gene therapies.
Global, Comprehensive Audit Support
Discover how a pharmaceutical company partnered with Advarra Consulting to establish a regulatory framework.
The Role of Financial Management and GAAP in Clinical Research
Learn how robust financial practices and a CTMS aligned with GAAP principles can drive sustainable growth and efficiency within an organization.
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.
What is an sIRB and Why Does my Study Need One?
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.
sIRB 101: An Introduction to Relying on an External IRB
Learn the basics of working with an sIRB and gain insights for successful sIRB relationships with external IRB partners.
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.
Device Risk Determinations for IVD Research
Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.
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