Regulatory Considerations for Pharmaceutical Product Lifecycle Management
As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations
sponsors
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
Q&A: The IND Journey Phase I – Navigating Success
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.
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.
Return of Research Results to Study Participants
Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and
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
4 Questions to Ask When Establishing a Pharmacovigilance Organization
Establishing a compliant pharmacovigilance (PV) function from scratch is often an overwhelming exercise for emerging biotech organizations, typically competing with
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.
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