Special Advertising Supplement: Schulman IRB

The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer, colloquially known as gene therapy research, to enter the mainstream. Gene therapy research involves the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring […]

Kaali Dass, PMP, PhD headshot

Integrated Clinical Analytics Model to Improve Business and Operational Excellence in Clinical Research

Innovation and technology are driving efficiency and performance in clinical research by changing the way data are captured, monitored, analyzed, and reported. Mobile and Internet-connected medical devices generate large volumes of data in an environment where data science, data discovery, and visual analytical tools are empowering clinical researchers and study teams to improve trial management, […]

David Borasky headshot

Applying ISO 9001 to the IRB Process

An institutional review board (IRB) is an independent body that reviews proposed human subjects research in order to ensure that proposed activities are in compliance with applicable regulations and the ethical principles described in the Belmont Report. The use of the term “institutional” in IRB is derived from the reality that most clinical research studies […]