Navigating Key Complexities in the Development of Cell and Gene Therapies
Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.
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.
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Learn practical strategies on how to improve diversity in clinical trials for historically under-represented groups.
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.
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.
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.
Sickle Cell Disease: The Importance of Amplifying Patient Voices
Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.
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.
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.
Simple Strategies for Identifying Research Compliance Blind Spots
David Staley authored the article Simple Strategies for Identifying Research Compliance Blind Spots in Compliance Today.