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!”
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!”
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.
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.
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.
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.
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.
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.
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.
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.
Gene therapy research continues its rapid expansion in the clinical setting, especially in infectious disease, rare disease, and oncology. To support discussion of emerging genetic research issues, Advarra presents its first virtual symposium.
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.
Experts from Advarra and Johns Hopkins University School of Medicine provided practical guidance on the COVID-19 research impact in a recent webinar. We’ve addressed the most popular Q&A topics here.