Clinical Trials

Biography

Biography: Suzanne Bishop

Abstract

The eClinical Forum – a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, have developed a regulatory-based assessment tool for EHR vendors or sites to determine if their EHR system is appropriate to hold regulated clinical trial data. This tool will help make the clinical research process more efficient, while furthering the use of EHR records for clinical research. It is offered free; there are no advertisements on the website and your information will not be used for other purposes. The eClinical Forum’s only intent is to make the process more efficient for everyone. Through the use of the eSource Readiness Assessment Tool (eSRA), EHR vendors can provide information to their customers who do clinical research, to help these clinical research sites determine if they are meeting regulations. The clinical research sites are already being asked these questions by their clinical research sponsors (pharmaceutical companies) and it can be timely to complete a different form for each research sponsor. By using the eClinical Forum tool, the site can complete just one assessment and give it to each of their sponsors. We have already shown this tool to regulators and had a favorable response – some are even presenting it at industry conferences. The more EHR vendors that participate, the easier it is for their sites to participate, and the more sites that participate, the easier it is for their sponsors to participate. If everyone uses this assessment form then it really does become a highly efficient way to gather the information that regulators want – information that shows that the systems that may originate data that could end up in a clinical trial has integrity.