Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
In a recent webinar, Advarra regulatory experts discussed the must-haves of FDA and Common Rule reporting requirements. They reviewed the basics of what must be reported to whom—and when—for sponsors…
Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
COVID-19 has focused the importance of diversity, equity, and inclusion considerations in clinical trial enrollment. How can the research community address the root causes for lack of diversity? What actions…
Global CRO Drives Study Startup Efficiency by Converting Local IRB Sites to Central IRB Review
Research sites that rely on a local IRB typically take at least twice as long to activate than sites that rely on the study’s single central IRB. Utilizing the central…
Q&A – The New Urgency of Clinical Trials: How Oncology Leads the Evolution
In Advarra’s recent virtual symposium, experts from industry and academia met to discuss how oncology research has influenced agility in clinical trial design, particularly during the COVID-19 pandemic. Panelists talked…
IRB Services: Central Oncology Review
Advarra’s Central Oncology Review service provides robust human subject protections review that cancer research institutions expect.
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, there are certain issues researchers must keep in mind, including whether those remote sites are considered to be engaged in research.
The Must-Haves of FDA and Common Rule Reporting Requirements
The Food and Drug Administration (FDA) regulations governing Investigational New Drug (IND) applications contain specific reporting requirements. Similarly, the Common Rule (i.e., the federal policy for the protection of human…
Community Consultation in the Time of COVID-19
How should sites conducting planned emergency research approach community consultation in the time of COVID-19?
How Oncology Research Is Advancing Better Research
The COVID-19 pandemic has challenged every aspect of the clinical research industry. This new urgency has affirmed certain clinical trial innovations originally pioneered in the oncology space.
The New Urgency of Clinical Trials: How Oncology Leads the Evolution
Join colleagues from the research community for a discussion on the evolution of clinical trials and how oncology research has influenced agility in clinical trial design.