A pharmaceutical company conducting a Phase III study of an investigational ointment required an eSource solution that could support remote monitoring, video uploads, and image capture and provide push-button randomization.
The sponsor worked with Clinical Ink to develop a custom “parent” eSource study according to sponsor protocol for electronic deployment. This used a tablet PC to electronically capture trial data during the subject visit. Immediately following the initial data capture, the sponsor accessed validated data in real time through a secure web portal to gauge subject reaction to dosing and determine further needs. Based on the remote review of this data, the sponsor was able to work with Clinical Ink to easily create and deploy in rapid succession a series of follow-up eSource studies to select sites. Clinical Ink secured IRB approval prior to deploying the updated eSource studies, which were sent every two weeks to test different dosing levels, patch sizes and locations.
Clinical Ink helped the sponsor reach database lock in less than one month by providing real-time remote access to validated clinical trial data for a highly complex adaptive clinical trial. Similar studies by the same sponsor using paper-based data capture processes required more than one year before database lock was achieved. In addition to successfully developing and controlling the deployment of a number of eSource studies for a series of adaptive clinical investigations, Clinical Ink played a key role in expediting IRB approval. The sponsor hit database lock in less than one month. Clinical Ink successfully developed a series of follow- up studies, securing prompt eSource regulatory review and approval and controlled bi-weekly deployment to select sites.
- Accelerated database lock (1 year to 1 month)
- Effectively expedited IRB approval
- Enabled real-time remote access to data
- Facilitated a highly adaptive trial design
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