Maintaining Data & Reporting Integrity with Mobile Health
As the COVID-19 pandemic has forced a shift toward remote modalities, mobile health (mHealth) technologies have been on the rise. […]
IRB
Future of Work in Clinical Research
When SARS-CoV-2 (the virus causing the disease COVID-19) broke out in 2020, the clinical research community needed to pivot quickly
Advarra Trend Report: The Future of Work in Clinical Research
Advarra conducted The Future of the Clinical Research Workforce survey in Summer 2021. This report reflects the survey’s findings.
Beginner’s Guide to Connected Clinical Research Ecosystems
A well-managed, participant-centric clinical trial has many moving parts, and easy access to the right technologies, services, and community of
Research Equity and Enrolling Non-English Speakers
Informed consent, a cornerstone of ethical research, involves describing important elements of research in a way that permits participants or
US Medical Device Regulation 101
Download a larger version of the infographic. IRBs and Researchers: Know Your US Medical Device Documentation Speed the IRB
IRB Review of Phase I Research: Balancing Ethics and Efficiency
Phase I research demands careful IRB oversight, balancing participant safety with timely reviews. Proactive strategies can help address its unique challenges.
Beginner’s Guide to Minimal Risk Research
When an institutional review board (IRB) determines research is “minimal risk” (as defined in Department of Health and Human Services
Ethical Issues in the Design and Review of Decentralized Research
Learn how to navigate ethical issues in decentralized research with insights for sponsors and IRBs on design and deployment strategies.
IRB Review of Social Media Recruitment and Retention Programs
Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. However, US regulations
The Value of Early Engagement with Your IRB
It’s no secret that in clinical research, everything moves at a quick pace – and that doesn’t stop when working
Study Activation: Top Four Takeaways from Research Sites
While enrolling subjects is arguably the most crucial aspect of clinical research operations, this cannot be done without activating a