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On-Demand Webinars

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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.

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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.

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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.

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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.

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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 ...

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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 ...

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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 ...

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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 ...

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The global COVID-19 pandemic has brought vaccine research to the forefront, and a surge of research involving genetically engineered vaccines is currently taking place. The availability of the viral genome ...

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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 ...

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