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
Consulting
Q&A – Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
In our latest webinar, a panel of experts from research organizations, Community Health Centers (CHCs) and healthcare tech discussed racial
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
By the Numbers: Our Response to COVID-19
We are honored to support a resilient research community during the COVID-19 pandemic. See the data points in our infographic to find out how Advarra helps keep research moving forward.
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
5 Tips for Successful Project Management in Clinical Research
Project management is a key part of every successful business, and the clinical research industry is no exception. Research organizations regularly encounter multi-tiered projects, such as system implementations and integrations. In essence, every clinical trial is a complex project that requires adequate planning and leadership to be successful.
Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
Racial Diversity in Clinical Trials: Building Trust in Participant Engagement While racial and ethnic diversity in clinical trial participation has
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.
3 Essential Elements of Change Management Within Clinical Research Operations At Your Research Site
The key to effective, productive change within a research institution lies at the nexus of people, process, and technology.
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.
What Do Auditors Look for When Performing SDV and SDR?
Subject safety and reliability of data are paramount in clinical research. This blog outlines what auditors look for when performing source data verification (SDV) and source data review (SDR) during routine investigator site audits.