Consulting
Defining Decentralized Clinical Trials and Understanding Their Nuances
It’s important to understand decentralized clinical trials are not one-size fits-all and oftentimes a hybrid approach is necessary. Read our latest blog outlining what to consider when rolling out decentralized clinical trials across multiple jurisdictions where laws, technological uptake, and populations will vary.
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.
Informed Consent: When, Why, and How It’s Obtained
Aside from being a regulatory and ethical requirement, informed consent is a good way to ensure participant knowledge and develop a foundation trust between researcher and participant.
Q&A: Institutional Responsibilities Under a Federalwide Assurance
Q&A from the Institutional Responsibilities Under a Federalwide Assurance (FWA) webinar and an overview of the FWA and its changes with the revised Common Rule.
Q&A – Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
Advarra's experts answer audience questions from our Regulatory Fine Points: Exploring 21 CFR Part 11 Validation webinar.
Expanding Our Global Consulting Expertise to Solve Mission-Critical Issues
Elevating our consulting capabilities to accelerate clinical research and bring therapies to market sooner.
Top 10 Educational Resources of 2020
We strive to create meaningful and relevant content for the clinical research community. Check out our top resources of 2020.
New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
Certificates of Confidentiality protect participant privacy by preventing disclosed sensitive information during research.
Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
FDA is placing an increased emphasis on compliance with 21 CFR Part 11. Institutions, health systems, IRB offices, private research clinics, and developers—to name a few—need to understand the basics of the regulation and how to comply.
Institutional Responsibilities Under a Federalwide Assurance (FWA)
When institutions are engaged in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance that they will abide the requirements of the Common Rule.
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