eSource
Background
Cmed believes the processes currently used to conduct clinical trials are out dated and under-performing. They were largely designed for use in the 1980s – before the technology explosion of the ‘90s – when processes were designed specifically to rely on manual checks and controls. The best example of this is Source Document Verification (SDV).
SDV is simplistically a manual quality check comparing source data at the site with data recorded on paper CRFs or eCRFs electronically loaded into the clinical database. It is designed to ensure that the data collected in a clinical trial is accurately transcribed between patient notes and the case report form. In a paper world, this step seems obvious. However, in an electronic world this step seems redundant. SDV is a means to an end, not an end in itself. Surely today our electronic solutions can better ensure our quality demands?
“The current clinical drug development paradigm is being challenged as being inefficient and producing information of limited use to practicing physicians”
Scott Gottlieb, MD – Deputy Commissioner for Medical and Scientific Affairs, FDA – July 2006
eSource will bring about the most profound change in the conduct of clinical trials for decades:
- Save considerable money
- Improve safety and decision making
- Reduce Investigator site workload
- Fundamentally smarter
Our groundbreaking Timaeus technology has always been designed with the Investigator at the centre of the clinical trial concept, and was developed with eSource specifically in mind. To find out more, contact Cmed.
