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.

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.

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.

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.

Making a Case for Interim HRPP Staffing

As much as we hate to admit it, many of us have been there…that moment when we suddenly realize “Oh no. I need to fill an HRPP position YESTERDAY. Help!”

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