Understanding the Complexity and Uniqueness of Phase I Trials
In clinical research, working with organizations that understand the ins and outs of the phase of your trial is key
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mRNA and Its Role in Clinical Research
In the race to address the COVID-19 pandemic, researchers have worked tirelessly the past year to produce a vaccine. Operation
Does Warp Speed Vaccine Development and Testing Compromise Safety?
A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while traveling at warp speed or
Top 10 Educational Resources of 2020
It’s safe to say 2020 has been more unpredictable than anyone could imagine. Through these unprecedented times, we have worked to provide the
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
Standardization and the Importance of Medical Coding Dictionaries in Clinical Trials
The data gathered in a clinical trial is often collected by many different people, including investigators and coordinators, and interpreted
The Many Faces of “Coercion” and “Undue Influence”
The United States regulations governing research with humans pay special attention to two ethical concepts that may not be familiar
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
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.