One event which you may have missed at DIA was the launch of a new suite of eClinical solutions by Techorizon, the technology subsidiary of CROMSOURCE. Applied Clinical Trials attended the launch, and got the company’s take on this latest release into the eClinical market, Th-eClinical. Currently, Th-eClinical comprises Th-eCRF, Th-eDiary, Th-eSurvey and Th-eLearning components and integrates fully with other Techorizon applications such as its Cloud CTMS and site feasibility tools to provide a comprehensive package of operational tools.
In a move in which it hopes to shake up the clinical technology industry, Techorizon’s solutions offer greater security, greater flexibility, shorter set-up time, and reduced costs. It does this by offering applications fully integrated or deployed independently and are accessible securely in real time via computer, tablet or smartphone connection with the Cloud.
So what’s new about Th-eClinical? While most systems used by the industry are compliant with the well-known requirements of CFR 21 Part 11, Techorizon develops its tools to the standards of GAMP 5. GAMP stands for Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture, released by the International Society for Pharmaceutical Engineering (ISPE), with the latest version 5 released in February 2008. So while its tools are also CFR 21 Part 11 compliant, the company believes GAMP 5 offers additional rigor.
Secondly, the pricing structure for Th-eClinical is based not on license fees but on actual levels of use, providing immediate cost benefits to the sponsor. Other factors that represent a change in approach, include smoother integration with existing client systems (including CTMS applications, data management software etc.) gained from embedded capability within the platform itself. In accordance with technology trends, all Th-eClinical applications can be deployed securely on a BYOD (bring your own device) basis. This approach allows users to use their own devices, which can save costs, while maintaining the familiarity of users’ own tablets or smartphones.