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.
CRO
Sites: The Key to Patient Centricity in Clinical Research
We’ve heard and used the term “patient centricity” for years now, and with good reason. It’s an important consideration in
Reflections from Cell and Gene Meeting on the Mesa 2021
I recently had the privilege of both presenting at and attending the 2021 Alliance for Regenerative Medicine (ARM) Annual Cell
Implementing a Quality Management System
Many research and development (R&D) organizations across the industry have limited access to a quality department in the early stages of
The Importance of Keeping DSMBs Independent
Establishing DSMB independence helps mitigate bias, ensuring clinical trials adhere to regulatory standards and build public trust.
Beginner’s Guide to Compliant Electronic Source Data Capture
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?
Research Equity and Enrolling Non-English Speakers
Informed consent, a cornerstone of ethical research, involves describing important elements of research in a way that permits participants or
Understanding International Data Transfer’s Impact
The landscape of data privacy is certainly dynamic and, at times, imposing. In particular, transferring data across borders can be difficult to navigate.
FDA Communications Through the Drug Development Lifecycle
As a drug makes its way through the development lifecycle, one of the most important relationships for a sponsor to
Data Integrity – It’s All About the Data!
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
6 Tips for Creating Effective Clinical Trial Training
Effective training for clinical trials requires clear, engaging content tailored to busy site staff. Focus on bite-sized learning, mobile optimization, and learner feedback.
IRB Review of Phase I Research: Balancing Ethics and Efficiency
Phase I research demands careful IRB oversight, balancing participant safety with timely reviews. Proactive strategies can help address its unique challenges.