The Future of Clinical Monitoring

Q4, 2010

It turns out that clinical monitoring is in no immediate danger of going the way of the dinosaurs. In fact, two-thirds of the respondents indicated they would recommend their son or daughter become a CRA. Status quo then, right? Not so fast, the times are changing. Now what?

This report details the overall awareness, interest, and potential adoption of alternative models for clinical monitoring; it uncovers the barriers to adopting these models; it gets at what phases of development are appropriate for the various mix of monitoring models; analyzes what pricing models are best for this highly outsourced activity; and broadens the industry's understanding of how the clinical monitoring landscape will likely change over the next few years.

The "now what" is a call to action. Biopharmaceutical sponsor companies are interested in alternative models for clinical monitoring and they portend some striking increases in their use. It is now up to the regulators, sponsors, technology providers, and clinical service providers to develop solutions that meet the industry's needs.

Report Contents:

This report contains the following three sections:

1. The changing times – Clinical monitoring is critically important to the drug development process, no question. But that does not mean it is a static process. This section provides evidence that times are changing and new clinical monitoring models have a place in the industry.

2. The changing models – This section focuses on the industry’s perspectives on which models are likely to be adopted and for which phases of development they are most appropriate. Barriers to adoption are addressed as are economic models preferences.

3. Why change? – Gives an overview of why it is going to be difficult to increase the adoption of newer monitoring models.

As always, an appendix of Charts and Graphs is also included within this report with responses to all questions asked in this study.