Reporting Requirements
Q&A Part I: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
Q&A from the Clinical Trial Feasibility: Ensuring Success for Clinical Sites webinar outlining why it is important for sites to approach research operations as a business.
FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
A Food and Drug Administration (FDA) inspection of a clinical investigator can occur at any time. The FDA conducts inspections of clinical investigators to verify clinical trial data submitted to FDA; to ensure that the rights, safety, and welfare of human subjects enrolled in FDA-regulated clinical trials are protected; and to assess regulatory compliance.
Leveraging a Central IRB Office to Improve Turnaround Times and Consistency
Legislation to Advance Equality and Inclusion in Oncology Clinical Trials
The Clinical Treatment Act and Henrietta Lacks Enhancing Cancer Research Act aims to increase diversity in oncology clinical trials
Remote Monitoring: Study Compliance in a Changing World
Effective remote monitoring plans enable sites and sponsors to maintain trial participant safety, data quality, and data integrity. With limited availability to access research sites in person over the past year, sponsors and monitors rapidly changed how they review study procedures, subject status, and study progress at research sites.
FDA Inspection Readiness: After the Inspection
Preparing for an FDA inspection and enabling a site-specific process to support it is important. Learn more about what to expect and implement after an FDA inspection is completed at your institution.
Clinical Trial Feasibility: Ensuring Success for Clinical Sites
With comprehensive research portfolios and a myriad of operational challenges to manage, it has never been more important for sites to approach research operations as a business.
FDA Inspection Readiness: During an Inspection
Preparing for an FDA inspection and enabling a site-specific process to support it is important. Learn more about what to know while undergoing an FDA inspection at your institution.
Above & Beyond: Better Utilize In-House Reporting Resources with Advarra Insights
Does your organization utilize your in-house reporting teams and systems to their full potential? Learn how a standardized business intelligence system could complement your current reporting structure to improve your organization’s operations.
UChicago Comprehensive Cancer Center Adopts Industry-Leading Research Administration Technology
Wayne State University Streamlines Compliance with Validation Services for Advarra EDC
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