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
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that
Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors and contract research organizations (CROs).
From live sessions to eLearning, scalable training models ensure clinical research teams stay effective, well-informed, and adaptable to new protocols.
Ensuring 21 CFR Part 11 compliance in research software protects data integrity, security, and audit trails, essential for meeting FDA electronic documentation standards.
IRB oversight, identity verification, and comprehension checks are critical in eConsent, ensuring ethical and legal standards while improving participant understanding.
eConsent in clinical trials enhances participant understanding and flexibility but requires careful planning, regulatory compliance, and IRB coordination to ensure success.
The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. In
Institutional biosafety committees (IBCs) frequently receive questions about the proper type of hood for use with biological materials and the
Cannabis use has become widespread. As such, we are seeing an uptick in research examining the therapeutic effects of cannabis
Short form consents provide a crucial bridge for unexpected non-English speaking participants, ensuring informed consent remains accessible when translations aren’t readily available.
Efficient document systems like eTMF and eISF enhance compliance and streamline document management, helping sites and sponsors ensure secure, organized trial records.
Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and