Why do Funding and Legal Structure Matter in Decentralized Clinical Trials?
Optimizing clinical trial access for potential patients is a critical goal for researchers and sponsors. How can we make clinical
Reviews
Large Clinical Research Site Network Streamlines Study Startup with Reliable, Timely ICF Writing Services
Discover how Advarra’s ICF writing services helped a site network create compliant, flexible processes, improving IRB submissions and timelines.
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
Establishing and Operating a DSMB: Tips for Clinical Trial Success
Learn how DSMBs safeguard trial integrity and participant safety with insights on setup, member selection, and the importance of independence.
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.
When Do I Need an EAC?
To better understand when you may need an endpoint adjudication committee (EAC), it’s helpful to know the EAC’s role in research.
Clinical Trial Superheroes
Explore the contributions of clinical trial superheroes, from coordinators to data analysts, improving patient health and outcomes.
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
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
Expedite Study Startup: Four Strategies to Optimize Site Activation
Learn how organizations can expedite study startup and avoid delays through streamlining site selection, training, ethics review, and site initiation.
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.