Sites
Beginner’s Guide to Single IRB Mandates
More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.
Medicare Coverage Analysis Worksheet
Determine whether your trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials.
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.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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 Now, FDA provides draft guidance on ethically including kids in trials.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’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.
Setting Yourself up for Success During Investigator-initiated Trials
This eBook shares tips and best practices to guide researchers through the investigator-initiated trial process while staying compliant.
Addressing Decentralized Pre-Enrollment Challenges for Sites and Site Networks
Learn key processes and tools for your team to use to ensure your organization operates at peak performance.
Yale Enhances Patient Safety, Billing Workflows with OnCore and EMR Integration
Read how Advarra created an integration connecting the OnCore CTMS with Yale’s EMR system to support a compliant billing process.
Modernizing Site Feasibility and Selection
An important decision impacting a multi-faceted study startup process is determining which sites to partner with for study conduct.
Site Streamlines Operations with Advarra EDC Study Design Service
Advarra’s Electronic Data Capture (EDC) Study Design Service was the solution to delivering high-quality eCRF builds to research staff.
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.
Subscribe to our monthly email
Receive updates monthly about webinars for CEUs, white papers, podcasts, and more.
Advancing Clinical Research: Safer, Smarter, Faster™
Copyright © 2024 Advarra. All Rights Reserved.