AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 7, 2023
New research from ETH Zürich in Switzerland could see future wearable devices (with perhaps a few implants and a touch of genetic engineering) boost our health directly. Fitness trackers help you stay healthy by keeping count of your steps and monitoring your heart rate, driving you on to hit those cardio goals.
Advarra
JUNE 13, 2024
When working with an unfamiliar IP, clinical personnel are likely looking for answers to three main questions: What are the risks associated with this IP? Replication-incompetent Agents Many viral vectors used in clinical trials today are genetically engineered with safeguards to render them replication-incompetent.
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Advarra
JUNE 12, 2023
Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. IBC membership must include involving two local community members who reside within 50 miles of the research site.
Advarra
MARCH 31, 2023
This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.
Velocity Clinical Research
OCTOBER 3, 2024
As Nick Spittal states in this Advarra press release, membership in the Gene Therapy Ready (GTR) site network “allows Velocity to start studies over a month faster and provides a meaningful credential and important validation that increases sponsors’ confidence in our specialized capabilities to conduct complex clinical research safely.”
WCG Clinical
AUGUST 27, 2024
The NIH Guidelines also stipulate that at least two members of each IBC come from the surrounding community and be unaffiliated with the institution where the research is occurring apart from their membership on the IBC. Many of those original concerns of the 1970s and 1980s surrounding genetic engineering have lessened over time.
Advarra
AUGUST 8, 2023
Risks and Regulatory Requirements Most clinical researchers are familiar with the regulatory requirements pertaining to the FDA phases of review as well as with IRB review. IBCs are comprised of at least five members, including at least two unaffiliated community members.
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