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.
Research Compliance
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
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.