How Sites Can Win in the New Age of Genetically Engineered Treatments
With gene therapy trials on the rise, sites must prepare biosafety protocols, facility standards, and partnerships to attract cutting-edge studies.
Research Compliance
Key Considerations for Regulatory Compliant Document Storage
Compliant document storage in clinical trials demands robust systems for security, accessibility, and retention to meet privacy and regulatory standards.
Informed Consent: When, Why, and How It’s Obtained
Informed consent isn’t just a formality—it’s an evolving process that safeguards participant autonomy and enhances study integrity from start to finish.
Q&A: Institutional Responsibilities Under a Federalwide Assurance
In a recent webinar, Advarra regulatory experts presented on the topic titled Institutional Responsibilities Under a Federalwide Assurance (FWA). Our
Q&A – Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
In a recent webinar, James Riddle, Shannon Roznoski, and Stuart Cotter of Advarra presented Regulatory Fine Points: Exploring 21 CFR Part
Utilizing eRegulatory Integrations to Expedite Regulatory Workflows
The processes necessary to support regulatory compliance require valuable time and resources within a clinical research institution. Regulatory tasks in particular require frequent
Expanding Our Global Consulting Expertise to Solve Mission-Critical Issues
Elevating our consulting capabilities to accelerate clinical research and bring therapies to market sooner. YourEncore, a leading provider of drug
Does Warp Speed Vaccine Development and Testing Compromise Safety?
A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while traveling at warp speed or
New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
FDA has recently issued guidance relating to changes for Certificates of Confidentiality (CoCs) brought about by the 21st Century Cures
The Many Faces of “Coercion” and “Undue Influence”
The United States regulations governing research with humans pay special attention to two ethical concepts that may not be familiar
Surprise! “Checking the Box” Is Still an Option on the Federalwide Assurance (FWA)
The Common Rule (subpart A of 45 CFR part 46) requires that each institution engaged in nonexempt human subjects research
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
As part of FDA’s response to combat COVID-19, FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC). The