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 […]

Jian Wang headshot

Good Management Practice: Improving Precision Medicine Trials by Extending RBM Principles to Include Specimen and Consent KRIs

Precision medicine represents a paradigm shift in the life science and pharmaceutical industry. An estimated 73% of oncology drugs and 42% of all drugs in development follow the precision medicine paradigm.1 Whereas the traditional model of drug development focuses on primary protocol endpoints, the precision medicine model further emphasizes exploratory endpoints and collection of separately […]

Mark Opler headshot

Myths and Realities of Placebo Response: A 21st Century Prescription

Randomized, placebo-controlled clinical trials are the most challenging and complex aspect of development and commercialization of new drugs. The costs of conducting trials have continued to increase, trending ever upward.1 A dispassionate observer might question how much added value is generated from the enormous investment involved in clinical studies. Is drug development becoming more successful […]