Q&A – The Evolving Role of Technology
In this Fireside Chat Q&A blog , CEO Gadi Saarony and Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, share perspectives on technology’s evolving role in clinical research.
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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?
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.
Fitting Your Needs: Pandemic-Proofing Protocols
With more than half of 2020 underway, it’s safe to say the year is not looking like anyone thought it
Introducing Fireside Chats: Conversations On Burning Research Topics
Advarra is excited to introduce Fireside Chats, a series of virtual conversations discussing current issues in clinical trials. Each Fireside Chat brings together perspectives from across the research community, enabling real-time discussion of contemporary challenges and potential solutions to help make research altogether better.
Q&A – The New Normal: Considerations for Restarting Research
In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider as we look to ramp up research in the COVID-19 pandemic’s “new normal.” In this blog our experts answer some of the most popular audience questions.
Q&A Part 1 – Gene Therapy Research in the Age of COVID-19
In Advarra’s inaugural virtual symposium, experts from industry and academia met to discuss the unique challenges gene therapy research poses for research sites, sponsors, CROs, and study participants.
Q&A Part 2 – Gene Therapy Research in the Age of COVID-19
In Advarra’s inaugural virtual symposium, industry and academic experts discussed overcoming obstacles and optimizing study startup in gene therapy research. They respond to more popular Q&A topics here.
Patient Engagement and the IRB
Recent years have seen increased efforts to engage with patient and participant communities and include them more closely in research. This approach is reflected in the founding of the Patient Centered Outcomes Research Institute (PCORI) as well as statements from the US Institute of Medicine and Food and Drug Administration (FDA) on the importance of including participant perspectives at every stage of the research process—from the design of studies through their implementation and the dissemination of research results.
For Sponsors and Sites, the Research Restart Effort Begins With Communication
The global pandemic has changed the way we think about research. Sponsors should consider how the “new normal” will impact sites and current studies as they plan to re-start research.
Safety Precautions for Laboratory Research With COVID-19 Specimens
The current global pandemic has brought biosafety to the spotlight. Biosafety practices must be customized to the proposed research as well as the existing facility and local regulatory requirements.
Trial Design in the Time of COVID-19: Complex and Efficient
Complex trial designs can eliminate less-promising investigational treatments quickly to speed development, but they remain under-utilized. The current pandemic offers a chance to consider strategies for facilitating adoption of such innovative designs.