Q&A – Site and Patient Engagement
CEO Gadi Saarony and Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, consider ways to improve site and patient engagement in this Fireside Chat Q&A blog part 2.
IRB
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.
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?
Clinical Research in the COVID-19 Era: Methods for Continuity
The COVID-19 pandemic has led to a significant shift in day-to-day research operations. To keep research moving forward, sponsors need to build a solid foundation to support the virtualization of key components of clinical trials. In addition, the industry needs to maintain a participant-centric approach while ensuring participant safety and regulatory compliance throughout the trial.
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!”
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.
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.
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.
Clinical Trials Day: Thanking the Unsung Heroes
On Clinical Trials Day, now more than ever, it’s important to recognize and thank those unsung heroes at the focal point of research: research sites and institutions.
Keep in Touch: Tips for Working with a Single IRB for the First Time
Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Many institutions must now establish policies and processes for working with an external sIRB.