Beginner’s Guide to Single IRB Mandates
As clinical trial efficiencies grow, understanding single IRB mandates becomes crucial for sites and...
FEATURED E-BOOK
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
Advancing Diversity, Equity, and Inclusion in Clinical Research: A Path Towards Health Equity
In clinical research, diversity, equity, and inclusion (DEI) is becoming increasingly recognized as...
Your Guide to sIRB Mandates
In the past few years, new regulations and policies have been announced and implemented...
Why Keep HIPAA Separate from the Informed Consent Form
The research informed consent form (ICF) is designed to provide prospective participants with the...
Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline...
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). It was the...
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of...
Patient-centric Clinical Trials: Evolving Strategies for Engagement and Retention
In the ever-evolving world of clinical research, patient engagement has become a critical...
Modernizing Site Feasibility and Selection
Study startup is a complicated, multi-faceted process – notoriously prone to delays due to...
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