How the IND 30-day Hold Impacts Clinical Trial Activities
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that
sites
Streamline Study Startup with Improved Site Selection & Feasibility
Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors and contract research organizations (CROs).
Scale Your Training Program: 3 Successful Models
From live sessions to eLearning, scalable training models ensure clinical research teams stay effective, well-informed, and adaptable to new protocols.
Beginner’s Guide to 21 CFR Part 11 Compliance
Ensuring 21 CFR Part 11 compliance in research software protects data integrity, security, and audit trails, essential for meeting FDA electronic documentation standards.
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.
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
Clean Bench vs Biosafety Cabinet: What’s the Difference?
Institutional biosafety committees (IBCs) frequently receive questions about the proper type of hood for use with biological materials and the
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
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