Does This Study Require IBC Review?
Gene therapy research is highly regulated due to associated risks, often leading to confusion among professionals new to its regulatory requirements.
Gene therapy research is highly regulated due to associated risks, often leading to confusion among professionals new to its regulatory requirements.
We’ve heard and used the term “patient centricity” for years now, and with good reason. It’s an important consideration in
I recently had the privilege of both presenting at and attending the 2021 Alliance for Regenerative Medicine (ARM) Annual Cell
Many research and development (R&D) organizations across the industry have limited access to a quality department in the early stages of
Establishing DSMB independence helps mitigate bias, ensuring clinical trials adhere to regulatory standards and build public trust.
While electronic source data collection is not new, collecting source data in a variety of settings in a compliant manner is. With this in mind, how does one maintain data quality and integrity while ensuring participant safety and staying compliant?
Informed consent, a cornerstone of ethical research, involves describing important elements of research in a way that permits participants or
The landscape of data privacy is certainly dynamic and, at times, imposing. In particular, transferring data across borders can be difficult to navigate.
As a drug makes its way through the development lifecycle, one of the most important relationships for a sponsor to
In this increasingly digital world, we have to remember data is now available in many different medians, including paper. When we think of clinical trials and the critical data
Effective training for clinical trials requires clear, engaging content tailored to busy site staff. Focus on bite-sized learning, mobile optimization, and learner feedback.
Phase I research demands careful IRB oversight, balancing participant safety with timely reviews. Proactive strategies can help address its unique challenges.