The growing cost of drug development is paving the way for newer technologies in clinical research. Taking its cue from success stories of automation across other industries, the pharmaceuticals sector’s acceptance of the Cloud, “big data,” and analytics stands as a testimony to changing times. The focus now is on risk-based monitoring (RBM) for enabling […]
A common career change for many people working in clinical research is to move from “operations” into “project management.” For some, this transition may be reasonably gradual; a person may over time take on responsibilities such as managing a work area or part of a budget. For others, the move into project management may be […]
Today, drug development is carried out in human subjects and animals. However, as computing power and the number of sophisticated technology platforms grow exponentially, and our knowledge of human health and disease increases, the virtualization of clinical research and development will grow steadily. Biosimulation (also called modeling and simulation), which integrates computer-aided mathematical simulation and […]
Whatever happened to “operational excellence”? It is a beautiful phrase and a worthy goal, but as biopharmaceutical companies and contract research organizations (CROs) start to dismantle or de-fund their Operational Excellence departments, we should ask what is happening. Do we no longer desire excellence? Do we think we have achieved it? Operational excellence arrived as […]
In The Catcher in the Rye, narrator Holden Caulfield dreams about saving kids from running out of a field of rye that has been planted right up to the edge of a cliff. The tragedy is that he cannot catch every kid if there really were a big game of chase being played in such […]
