Enhancing Research Conduct Using eConsent
eConsent in clinical trials enhances participant understanding and flexibility but requires careful planning, regulatory compliance, and IRB coordination to ensure success.
Research Operations
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
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.
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.
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