CBD Research: A Dive into the Regulations of Cannabis Research
Cannabis use has become widespread. As such, we are seeing an uptick in research examining the therapeutic effects of cannabis […]
Research Compliance
Short Form Consents and the Unexpected Non-English Speaking Participant
Short form consents provide a crucial bridge for unexpected non-English speaking participants, ensuring informed consent remains accessible when translations aren’t readily available.
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites and sponsors ensure secure, organized trial records.
Common Pitfalls in Preparing an IND Application
As a drug successfully makes it through the development process, sponsors will inevitably need to submit a new drug application
Common Elements of IRB Assessments
Like every institutional review board (IRB) – commercial or local – Advarra is subject to inspections from time to time.
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
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
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
Reuniting and Reconnecting at the 2022 Onsemble Conference
Throughout the day on Tuesday, March 29, clinical research professionals arrived at the Westin Savannah Harbor Golf Resort & Spa
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