Research Compliance
Realizing the Benefit of Mobile Technology in Your Clinical Trial
The use of mobile technology has been trending since smart phones hit the mainstream over 10 years ago. But the life science industry is still in the early stages of figuring out how to use mobile devices to deliver value to clinical trial patients and sponsors.
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.
James Riddle and Luke Gelinas Explore Digital Health and Regulation
This podcast covers an array of topics as they explore how COVID has been a catalyst for change, what digital health means for running clinical trials, and how sponsors, CROs, sites, and IRBs can consider when reviewing new digital technologies as a result of COVID.
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
Building Remote Workflows within eRegulatory Document Management: Subject Binders & SOPs
Advarra eRegulatory Management System now supports the storage and remote monitoring of Subject Binders and SOPs, increasing compliance, and centralizing your study documents.
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.
How Technology Can Improve Regulatory Efficiencies During the COVID-19 Pandemic and Beyond
Sites and life sciences companies have quickly adopted remote workflows to keep trials moving, and these changes are sure to inform our “new normal” as we look forward.
How Technology and System Integration Can Improve Your Billing Compliance
The consequences of inaccurate billing can be severe, and ensuring workflows are being followed by all teams across an institution can be a difficult process.
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.
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.
GCP Assessment During COVID – “Did Your Clinical Trials Remain GCP Compliant During COVID-19?”
Almost a year into the COVID-19 pandemic, analyze how IRB submissions, informed consent, and remote monitoring practices have maintained GCP compliance.
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