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Risk Assessment for use of Engineered Genetic Materials in Clinical Research
Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.
How Single IRB Review Mandates Help Research Sponsors
The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
Diving into Single IRB Implementation
In this episode, we get an inside look at how institutions implement sIRB requirements and how to overcome potential challenges.
Understanding how to Build and Leverage a DSMB Statistical Plan
Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.
What is a Quality IRB Review?
Measuring IRB quality is often an effort to determine whether an IRB’s actions improve research participant protections.
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.
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.
Investigating Enrollment Reliability with the Longboat Platform
Download the case study to learn if the Longboat Platform helps sites more accurately set and reach their patient recruitment targets.
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.
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