Tagged: Remote Monitoring

Risk-Based Monitoring: Where are the Benefits?

I got a call this morning from a frustrated colleague who runs the oncology franchise in Europe for a big pharma company. Despite a substantial investment in software that promised increased focus and efficiency through risk-based monitoring, my colleague is seeing neither. Did I have any suggestions? Questions about why technology is not producing expected… Read more »

Predicting the Future of Your Next Clinical Trial

A lot of people think the past predicts the future. I guess if you don’t have anything better, then there’s some truth to that. Recently I got a solicitation from Quintiles telling me just how valuable their database of past history is. You’ve probably heard the same promises – we know which sites produce, what… Read more »

Tilting the Playing Field in Clinical Development

Recent discussions with a large sponsor were a pleasant reminder that big doesn’t have to mean backward. This progressive company has made a start at adaptive (risk-based) monitoring. The goal of the clinical team is to achieve equal or better data quality at lower cost while prioritizing critical data and reducing timelines. One reason that… Read more »

Clinical Development Relay: The Hurdles We Face

Now that I’ve had the chance to settle in to the blogosphere, I’d like to tell you a little more about what I hope to accomplish with “Trials Without Tribulations.” It is obvious to me (and others in the industry, see here, here, and here) that biopharma faces a number of sizable challenges. Tribulations, if… Read more »

Improving Pharma Productivity One Step at a Time

I had a rare and refreshing experience yesterday afternoon. In meeting with a startup team from a big pharma company, the subject of source data verification came up. We like to use a digital pen CRF as source data, obviating the need for source data verification, one of the most inefficient steps in the research… Read more »