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Ace Your Next FDA Inspection
Discover valuable insights and expert guidance on navigating FDA inspections in clinical research.
Biotech Organization Partners with Advarra to Become Inspection Ready
A biotech organization becomes inspection ready through Advarra's GxP services and successful U.S. Food and Drug Administration guidance.
4 Unique Challenges of Oncology Trials
Oncology research is unique in many ways, including the challenges researchers face in conducting cutting-edge trials.
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.
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