Reporting Requirements
FDA/OHRP Harmonization and Your HRPP Operations
This webinar will discuss the human research protection program (HRPP) opportunities and challenges through FDA and OHRP harmonization.
Beginner’s Guide to IRB Review of IVD Research
If an investigational in vitro diagnostic (IVD) device is used in clinical research, it may require IRB review.
University of Nebraska Medical Center Streamlines Regulatory Management and Accelerates Study Startup with Advarra eReg
Learn how Advarra eReg helps UNMC support remote monitoring and how eReg helped address prevalent challenges in clinical research.
Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
Is Your Site Ready for an FDA Inspection?
Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.
Trend Report: 2023 Trends Impacting Clinical Research
This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.
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.
Ensuring Recruitment and Compliance Success of an Evolving Rare Neuromuscular Disease Study
Find out how the Longboat Platform ensured not only recruitment success, but site and participant support and compliance.
Rare and Orphan Diseases in Regulated Development
In this webinar, gain an in-depth understanding of regulatory and clinical development challenges for rare/orphan diseases.
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.
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.
How Paper and Electronic Source Data Meet ALCOA-C Principles
ALCOA ensures source data is safe and effective, but how does it differ for data collected on paper vs. electronically?
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