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 ...
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.
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 ...
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 ...
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 ...
Special Considerations for Pediatric Trials
In this white paper, get to know the key considerations for researchers conducting pediatric clinical trials.
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 ...
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 ...
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.
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.
Transforming Your Research Administration Structure to Attract Research Opportunities
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.
Considerations for Using eTools in Research: Part 11 & System Validation
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 ...