White Paper

The Critical Role Sites Play in the Evolution of Clinical Trials

Drawing on the perspectives of experts from Parexel and Advarra, this white paper explores the evolving role of technology in clinical research and its impact on research sites and study ...

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White Paper

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

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

sIRB Review for Multicenter Research: A Guide for Institutions

Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...

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White Paper

Informed Consent: 6 Approaches to Increase Participant Comprehension

Ensuring participants have appropriate knowledge of a study is a crucial goal of the informed consent process. This paper describes six research-based approaches for improving informed consent and supporting participants’ ...

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White Paper

Managing Conflicts of Interest in Clinical Research

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

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

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

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

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

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

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?

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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