April 18, 2017Regulatory
We are very pleased that the article Dr Jules Mitchel recently wrote with Jonathan Helfgott is being featured in Applied Clinical Trials this month (click here to see the article). The public recognition of what we have done, what we are doing and the vision as to where we are going with the paperless clinical trial, is quite rewarding. We are confident that we have an industry changing approach to the paperless clinical trial and welcome doing a proof of concept with any company, and for any trial, no matter the size.
In the article, we assess the impact of electronic systems on several areas of a clinical trial, and how this is becoming a common fixture in routine pre-approval inspections and application review. We then present a guide to assuring eSource (the Paperless Clinical Trial) tools used for studies will support regulatory scrutiny.