Does This Study Require IBC Review?
Gene therapy research is highly regulated due to associated risks, often leading to confusion among professionals new to its regulatory requirements.
Reviews
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
Reflections from Cell and Gene Meeting on the Mesa 2021
I recently had the privilege of both presenting at and attending the 2021 Alliance for Regenerative Medicine (ARM) Annual Cell
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.
Video: Introduction to Data Monitoring Committees
Transcript The way we conduct clinical research is changing. More studies now require oversight from an independent Data Monitoring Committee
When do I Need a DMC?
Understanding when to use a Data Monitoring Committee (DMC) is crucial for participant safety. A DMC independently reviews data to spot early evidence of harm.
The Importance of Keeping DSMBs Independent
Establishing DSMB independence helps mitigate bias, ensuring clinical trials adhere to regulatory standards and build public trust.
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