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.
Reporting Requirements
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
The ROI of eRegulatory and eIRB Integration
Integrating eRegulatory and eIRB systems streamlines document management, enhances compliance, and delivers significant ROI through time and cost savings per protocol.
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
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.
5 Considerations for Evaluating an eIRB System
In addition to other responsibilities, human subjects protection programs (HRPPs) and IRBs are tasked with ensuring a research protocol’s lifecycle
The Powerful Potential of Open Collaboration
Advarra’s Site-Sponsor Consortium emphasizes shared standards and transparent dialogue, paving the way for scalable, collaborative research advancements.
Clinical Endpoint Adjudication Committees: Not Just for “Endpoints”
This blog outlines some of the critical events where endpoint adjudication committees (EACs) can be used to look at more than just “endpoints” in clinical research.
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.
Why Device, Diagnostic, and Digital Therapeutic Research Needs Endpoint Adjudication
In its March 2006 guidance, Establishment and Operations of Clinical Trial Data Monitoring Committees, the U.S. Food and Drug Administration