Webinar
Biosafety, Ethical, and Logistical Challenges to Pursuing a Coronavirus Vaccine at Warp Speed
The SARS-CoV-2 pandemic has impacted all aspects of society. Various government and private groups around the world are endeavoring to develop safe and effective vaccines at an unprecedented pace and scale to quell the pandemic as quickly as possible.
Creating an Integrated Approach to Regulatory Management at Your Institution
Over the past year, clinical research professionals have faced unprecedented challenges related to both the clinical and operational management of their research. Maintaining regulatory compliance and visibility within an increasingly remote environment has been a key focus area for many institutions.
Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
FDA is placing an increased emphasis on compliance with 21 CFR Part 11. Institutions, health systems, IRB offices, private research clinics, and developers—to name a few—need to understand the basics of the regulation and how to comply.
Institutional Responsibilities Under a Federalwide Assurance (FWA)
When institutions are engaged in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance that they will abide the requirements of the Common Rule.
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
In this webinar, Luke Gelinas, IRB Chairperson at Advarra, proposes a practical framework for evaluating offers of payment and applies it to case studies to yield guidance on challenging ethical and regulatory issues involved in paying research subjects.
How Medicare’s New Imaging Program Affects Clinical Trials in Oncology
Billing compliance is an essential part of clinical trial participation, and this is especially important for high-cost services such as CT scans, PET scans, nuclear medicine, and MRIs. However, organizations ...
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 ...
Research Staffing Strategies During Challenging Times
With hiring freezes, furloughs, in-person restrictions, and changes in workflows and documentation, the COVID-19 pandemic has had a significant effect on clinical research staffing. What will it look like when ...
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 ...
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 ...
Build a Better Budget: Using Medicare Coverage Analysis to Streamline Study Startup
Need to improve your study startup timelines? Consider adding a Medicare Coverage Analysis (MCA) to your toolkit. By leveraging an MCA when building your clinical trial budget template, you can ...
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.
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