Trend Report: 2023 Trends Impacting Clinical Research
This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.
Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.
How to Optimize Your sIRB Experience
Find out how other institutions have used sIRB requirements as an opportunity to elevate their research programs in this webinar.
SubjectWell Features Advarra Experts James Riddle and Luke Gelinas in White Paper
In a recent article, SubjectWell interviewed Advarra's James Riddle and Luke Gelinas, Compensation norms create inequity in clinical trials".
Updated Advarra Fee Schedules Now Available
TAdvarra’s updated fee schedules for IRB, IBC, DMC, and EAC are now available. The new fee schedules are effective January 1, 2023.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
Why Keep HIPAA Separate from the Informed Consent Form
HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.
FDA Proposes Revised IRB Regulations, Including Required sIRB for Multisite Trials
The FDA released two proposed rules intended to partially harmonize its current regulations with the Revised Common Rule.
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.
Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software
Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.
Unpacking IRB Innovations for Decentralized Clinical Trials
Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.