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 […]
Research Compliance
Q&A – Study Startup Success for the New Generation of Genetically Engineered Vaccines
In a recent webinar, Advarra Executive Director of Biosafety Services Daniel Eisenman discussed the latest trends in genetically modified vaccine and immunotherapy studies. He also explored unique startup challenges for studies involving investigational products that contain engineered genetic materials. Due to time constraints he wasn’t able to answer all audience questions during the Q&A period, so he has answered some of the most popular questions in this blog.
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
Is GDPR Coming to the US? CCPA and Its Impact on Research
Remember on the older The Price Is Right game shows with Bob Barker, when the announcer would describe to the contestant they could win “a brand-new car!” and then proceed to describe the car? Part of the description was always that the car had “and California emissions.” Why was that? What was so special about California? Turns out the state of California had different, more restrictive, pollution rules from the rest of the country; and if you wanted to sell cars in California you had to meet the California standards. It was difficult for car manufacturers to produce cars separate just for California, so eventually the country normalized on one standard, which looked a lot like the original California emissions standard.
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.
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, there are certain issues researchers must keep in mind, including whether those remote sites are considered to be engaged in research.
Community Consultation in the Time of COVID-19
How should sites conducting planned emergency research approach community consultation in the time of COVID-19?
How Oncology Research Is Advancing Better Research
The COVID-19 pandemic has challenged every aspect of the clinical research industry. This new urgency has affirmed certain clinical trial innovations originally pioneered in the oncology space.
IRB Review of Virtual Trial Technologies
Our webinar proved so popular, we thought a deeper dive would be appropriate. In this post we explore some key issues IRBs face when reviewing research involving virtual trial technology.
Accelerating the Recovery – Design and IRB Review of Safety Monitoring Plans During COVID-19
How do remote visits and data collection impact participant monitoring? What techniques will satisfy the regulatory obligation to conduct safety and data monitoring in this new remote research world?
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.
The Opioid Crisis in America
The opioid crisis in particular is staggering in the number of lives it has claimed. Combating the crisis requires urgent, evidence-based approaches that addresses clinical, research, and education issues.