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
Reviews
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
Why Institutions Should Consider an Externally Administered IBC
Clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine.
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
Understanding the Current and Future States of Cell and Gene Therapy Research
Explore the current and future landscape of gene therapy research, from advancements in oncology to strategies for improving review efficiency.
Cell & Gene Therapy vs Drug Research: What’s the Difference?
Cell and gene therapy’s popularity has grown exponentially in the past year. However, it’s important to understand how cell and gene therapy research is different from traditional drug development.