Laura LaRosa, RN, MS, President, Sheldon Clinical Trials Consulting, Inc.

Is CRA Fraud Undermining Clinical Trial Integrity?

Nearly 85% of clinical research associates (CRAs) were fraudulently documenting informed consent during a Phase III trial involving more than 100 sites, according to an observational study of several clinical trials conducted by Laura LaRosa, RN, MS, president of Sheldon Clinical Trials Consulting, Inc. “I think [some form of clinical operations documentation fraud] is happening […]

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, […]