A Checklist for Optimizing Clinical Trial Study Startup Activities
From protocol design to site training, optimizing study startup requires meticulous planning and collaboration to ensure timely trial activation.
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Best Practices in Pre-Screening Includes Use of Technology
Pre-screening subjects is common practice at most sites. In this article, learn some best practices and how technology can play an important role.
Common Elements of IRB Assessments
Like every institutional review board (IRB) – commercial or local – Advarra is subject to inspections from time to time.
Q&A: Stepwise Implementation of a Clinical Quality Management System
Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. Q: How
Centralization: Nurturing an Innovative Mindset in Clinical Research
Did you know 70% of the variance in team engagement is attributed to an employee’s direct manager? This means the
Building an Agile Workforce in Clinical Research
Most organizations understand the importance of creating a competitive advantage with a targeted, aggressive hiring strategy – but why is
Beginner’s Guide to Pre-IND Meetings
New to the process of helping to bring a drug to market? As intimidating as the Food and Drug Administration
Clinical Trial Associates and the Future of Pharma
Now more than ever, there is enormous pressure to deliver products to the market faster and cheaper. In the clinical
What do I do About Incidental Findings in Research?
An incidental finding is a “finding” or result from an intervention or test that uncovers a condition or problem that
What Goes into a Charter for DSMB or Endpoint Adjudication?
Learn the essentials of creating a robust charter for DMCs and EACs—an indispensable tool for clinical trial oversight and regulatory compliance.
mRNA Clinical Trials: Key Regulatory Considerations
Over the past two years, Operation Warp Speed brought mRNA-based vaccines into the spotlight, as organizations like Moderna and Pfizer/BioNTech
A Look at the Processes Behind Clinical Endpoint and Event Adjudication
See how Advarra’s tech-enabled adjudication platform leverages expert collaboration and secure data integration to streamline clinical endpoint evaluation.