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ICH-GCP Guidelines and Research Conducted in the US
Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.
Addressing Key COVID-19 Challenges Through Enterprise Technology
Throughout the COVID-19 pandemic, research institutions have addressed a wide array of challenges to keep research moving. As we look forward, many institutions still have unanswered questions on how to conduct research and build efficient operational strategies in the face of tighter budgets and limited resources.
IRB Review of Virtual Trial Technologies
What are some of the key issues IRBs face when reviewing research that includes virtual trial technology? Read more:
Updated IRB Policy on Blood Volumes in Research
Advarra has updated its IRB policy for documenting total blood volume in research. The study ICF must include the number of blood draws a participant will experience, and the protocol must include general information about blood draws.
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.
Legal Notice of Name Change
Both Schulman IRB and Chesapeake IRB will retain d/b/a status for an interim period and continue to operate under the current structure. Beginning in January 2018, customers will be contacted to amend and assign contracts as necessary. No action is required from you at this time.
20th Annual Human Subject Protection Conference
Join us Thursday, October 4, for our annual conference Human Subject Protection: Roll With It. Registration is now open.
Proposed Changes Released for Review of Gene Therapy Research
NIH has published a proposal to amend the NIH Guidelines to streamline oversight for human gene transfer research and reduce duplicative regulatory reporting requirements.
Understanding the Complexity and Uniqueness of Phase I Trials
There are many distinctions that set Phase I trials apart from the rest. For sites aiming for a successful Phase I trial, working with an organization that understands the nuances is key.
Hurricane Florence
At this time, we do not anticipate any disruption to Advarra's IRB meeting schedule, timelines or regular office hours due to Hurricane Florence.
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