Remote Monitoring

Monitor for a reason, not through habit

It is often the case that CRAs  visit sites every 4-6 weeks as per static monitoring plans, rather than  through specific need. The cost of sending an expensive resource to a site is not to be under-estimated – especially when time, travel, accommodation costs are considered.

The major component of any typical study budget is clinical and clinical project management, with potentially as much as 35 – 40% of the budget being monitoring alone..

The processes currently used to conduct clinical trials have many flaws as they were designed for use in the 1980s and intended for simple studies (and indications). They were also aimed at small molecules when access to current, complete data was not an priority. The investigation of biologicals with their potential for producing major safety issues quickly changes this making access to current data a requirement.

Traditional processes remain labour intensive and expensive whilst being technology averse.

The Cmed Approach: a better way forward

The FDA’s critical path initiative, the advent of new technology such as Timaeus, and the application of innovative data management practices allow Cmed to challenge the entire clinical trial process; reducing costs and, once again, enabling our clients to do more with less.

If a clinical team has access to a comprehensive and current set of both study data and performance metrics, they can then target the use of their most expensive resource, CRAs, to those sites which would derive greatest benefit.  Timaeus can enable this precision targeting sites for a number of reasons including:

• High recruitment
• Low recruitment
• High rate of automatic edit check firing
• High query rate
• Many protocol deviations

The upshot of this is that:

• CRAs manage the study site and regulatory compliance
• Data managers clean the data
• Technology is the enabling piece