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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

February 28, 2020

Clinical research with minors poses several significantly different issues than research conducted on adults. Therefore, researchers must address a number of special considerations when conducting any pediatric clinical trial.

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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?

January 15, 2020

The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened ...

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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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