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White Paper

Clinical Research in the COVID-19 Era: Methods for Continuity

July 30, 2020

The COVID-19 pandemic has led to a significant shift in day-to-day research operations. To keep research moving forward, sponsors need to build a solid foundation to support the virtualization of ...

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White Paper

Informed Consent: 6 Approaches to Increase Participant Comprehension

Explore six approaches for improving informed consent and supporting participants’ understanding of the studies they are asked to join.

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White Paper

Managing Conflicts of Interest in Clinical Research

February 28, 2020

Managing conflicts of interest in clinical research is a critical mission for many reasons. Here we discuss the need for conflict of interest policies in clinical research, examine the specific ...

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White Paper

The Convergence of GDPR, the HIPAA Security Rule, and Part 11 on US Clinical Research

February 28, 2020

As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ...

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White Paper

Botanical Medicines in Research

February 28, 2020

Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This whitepaper describes rationale for why IRBs should ...

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White Paper

Special Considerations for Pediatric Trials

In this white paper, get to know the key considerations for researchers conducting pediatric clinical trials.

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White Paper

10 Tips for Writing Compliant Participant Materials

February 28, 2020

Recruitment materials are a potential participant’s first introduction to the study, and post-consent materials can influence an individual’s decision about continued participation. It is important to adhere to the principles ...

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White Paper

Research in Pediatric Populations

February 28, 2020

It is vitally important to develop effective and safe treatments for children based on reliable data from clinical trials involving child participants. However, conducting research with children presents unique ethical ...

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White Paper

6 Tips for Submitting a Research Study for Expedited Review

February 28, 2020

Becoming familiar with the expedited requirements is a good way to ensure you can navigate the review process effectively.

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White Paper

What Level of Review Does Your Study Need?

In this infographic, we share useful information for investigators to know which level of IRB review likely applies to their study.

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White Paper

Transforming Your Research Administration Structure to Attract Research Opportunities

August 20, 2019

Institutions, health systems, and academic medical centers can dramatically increase their profile in the research community and attract major studies that move medical science forward on a global scale.

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White Paper

Considerations for Using eTools in Research: Part 11 & System Validation

July 10, 2019

Is your organization ready for an audit of your electronic systems? Advarra Consulting provides comprehensive support for compliance with 21 CFR Part 11, HIPAA/HITECH, and EudraLex Annex 11. Training and ...

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