Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
To maintain Part 11 compliance, research sites must validate electronic systems storing FDA-regulated records, safeguarding data integrity and accuracy.
Research Compliance
How to Be Research Ready: Today and Beyond
Research readiness ensures that your organization can accept, activate, and adapt to new studies and opportunities no matter the regulatory circumstances.
Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
The past year has been one of the most challenging ever for those working in healthcare and clinical research. The
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
In a recent webinar, Advarra experts Constance Cullity and Michele Russell-Einhorn presented FDA Inspections of Clinical Investigators: Understanding the Process
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts
Legislation to Advance Equality and Inclusion in Oncology Clinical Trials
According to the Association for Clinical Oncology, individuals who identify as African American or Black make up 13.4% of the
Building Remote Workflows within eRegulatory Document Management: Subject Binders & SOPs
Centralizing subject binders and SOPs in an eRegulatory system streamlines remote monitoring, ensuring secure access, compliance, and future-ready workflows.
How Technology Can Improve Regulatory Efficiencies During the COVID-19 Pandemic and Beyond
As we begin to emerge from the challenges of the COVID-19 pandemic, it’s clear that the post-pandemic landscape differs from
How Technology and System Integration Can Improve Your Billing Compliance
System integration streamlines clinical trial billing, ensuring accurate charge routing and reducing compliance risks through centralized workflows.
FDA Inspection Readiness: After the Inspection
In the final part of the three-part FDA inspection readiness series, we will go into detail about what to expect
FDA Inspection Readiness: During an Inspection
In our previous blog, FDA Inspection Readiness: Preparing for an Inspection we reviewed how to prepare for a Food and
GCP Assessment During COVID – “Did Your Clinical Trials Remain GCP Compliant During COVID-19?”
We are now almost a year into the COVID-19 pandemic, and you may be asking whether your clinical trials remained