Keys to Advancing Your Biotech Go-to-Market Plan
For nearly 10 years, a growing biotech company worked to develop a nitric oxide and delivery device for babies in […]
Research Compliance
Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations
In medical device research, the determination of “significant risk” or “nonsignificant risk” is sometimes confusing, especially for those new to
Research Involving Cosmetics: What you Need to Know
The Food and Drug Administration (FDA) is a U.S. public health authority within the Department of Health and Human Services
It’s Time for Sites to “Bring Your Own Technology” (BYOT)
Sites gain control with Advarra’s BYOT approach, eliminating redundant tasks and fostering efficient collaboration between research stakeholders and participants.
Critical Steps for Writing an Impactful Clinical Audit Report
The amount of detail required in an audit may vary – ranging from an executive, high-level summary with detailed observations,
Budgeting and Billing Compliance in Study Activation
Effective billing compliance starts with understanding routine costs, extended coverage, and administrative fees to avoid costly errors in clinical trials.
Navigating the FDA Emergency Use Filing Process
In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one
Developing an Emergency Preparedness Plan for your HRPP
The COVID-19 pandemic highlighted the importance of robust emergency preparedness for HRPPs, ensuring research continuity and participant protection during crises.
Considerations for Transitioning from Paper to eSource
Switching from paper to eSource in clinical trials enhances data accuracy, reduces errors, and boosts organization, offering more efficient study management.
Q&A: FDA Updates: BIMO – What Sponsors Need to Know
Advarra experts Joan Versaggi and Leslie Paul answer questions from the first in the webinar series – FDA Updates: BIMO
Unique Ethical Issues in Phase I Oncology Studies
Phase I oncology trials present distinct ethical challenges, such as participant vulnerability and the risk of therapeutic misconception, requiring careful oversight.
Does This Study Require IBC Review?
Gene therapy research is highly regulated due to associated risks, often leading to confusion among professionals new to its regulatory requirements.