Q&A Part II: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
In a recent webinar, Advarra experts Wendy Tate and Cheryl Byers provided considerations for building an effective feasibility process, including […]
Reporting Requirements
Q&A Part I: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
In a recent webinar, Advarra experts Wendy Tate and Cheryl Byers provided considerations for building an effective feasibility process, including
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
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
Above & Beyond: Better Utilize In-House Reporting Resources with Advarra Insights
With Advarra Insights’ core dashboards, research institutions streamline reporting, allowing custom teams to target institution-specific data needs.
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.
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
Beginner’s Guide to Investigator-Initiated Trials
While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or contract research organizations (CROs), other trials
Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
In a recent webinar, Advarra regulatory experts discussed the must-haves of FDA and Common Rule reporting requirements. They reviewed the basics of what must be reported to whom—and when—for sponsors and investigators involved in IND studies, as well as requirements for identifying, reviewing, and reporting unanticipated problems and noncompliance to IRBs and Common Rule departments or agencies. Due to time constraints we weren’t able to answer all audience questions during the Q&A period, so our experts have answered some of the most popular questions in this blog.
Community Consultation in the Time of COVID-19
How should sites conducting planned emergency research approach community consultation in the time of COVID-19?
Vendor Qualification vs Requalification Audits: What’s the Difference?
Different types of audits can be performed to support your vendor qualification and management program. These audits should be conducted using a risk-based approach. In this blog, we outline the difference between these types of audits and how to identify vendors that have the most potential risk for your program.