Research Compliance
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.
Beginner’s Guide to Budget Negotiation
Proper trial financing ensures internal costs are covered, facilitates better negotiation, and leads to higher compliance in trials.
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.
Simple Strategies for Identifying Research Compliance Blind Spots
David Staley authored the article Simple Strategies for Identifying Research Compliance Blind Spots in Compliance Today.
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.
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Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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 Now, FDA provides draft guidance on ethically including kids in trials.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.
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.
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