Regulatory and Ethical Considerations for eConsent in Research
IRB oversight, identity verification, and comprehension checks are critical in eConsent, ensuring ethical and legal standards while improving participant understanding.
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An Evolving Regulatory Environment for Rare and Orphan Diseases
Rare diseases affect fewer than 200,000 people each, totaling around 30 million in the U.S. Orphan drugs face R&D barriers, but FDA support has increased since 1983.
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.
5 Questions to Ask Your Sponsor for DCT Implementation
The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. In
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.
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