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sIRB 101: An Introduction to Relying on an External IRB
Learn the basics of working with an sIRB and gain insights for successful sIRB relationships with external IRB partners.
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.
New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy
Explore insights on new CMS policies & Medicaid's fresh clinical trial policy. Stay updated in a rapidly evolving healthcare landscape.
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.
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