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
Consulting
Advarra Trend Report: The Future of Clinical Staff Development Planning
The report provides information based on surveys and interviews with organizational leaders from top U.S. biotech and pharmaceutical companies.
Ensuring Success with Clinical Development Planning
This white paper outlines key elements of a CDP, including Treatment population, Demonstration of efficacy, Demonstration of safety, Clinical supplies, and Timing of activities.
The Clinical Development Plan: Executing the Clinical Strategy
This white paper outlines key elements of a CDP, including Treatment population, Demonstration of efficacy, Demonstration of safety, Clinical supplies, and Timing of activities.
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,
Understanding Various Decentralized Terms in Research
As many research organizations are becoming more patient-centric and adapting to technological advancements and remote requirements, they are re-designing the
GDPR Implementation Support
Expert assistance from Advarra’s regulatory consulting team enabled iSpecimen to implement GDPR with no service interruption to their Eurozone customers.
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.
For FDA Inspection Readiness, Accountability is Key
Dawn Wydner, former Food and Drug Administration (FDA) Consumer Safety Officer, LCDR, and current Managing Expert for Advarra’s Quality Center
Top 10 Educational Resources of 2021
The year 2021 brought many advancements in the clinical research industry. We’ve pushed for more diversity and inclusion in clinical
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