This Small Business Innovation Research Phase I project will establish technical merit and feasibility of developing a Software-as-a-Service (SaaS) application for Electronic Data Capture (EDC) development in clinical trials. Suffering from the disadvantages in both adoption models and technologies, today's EDC solutions in clinical trials are expensive and difficult to be implemented. The goal of this project is to develop a new and innovative SaaS application which will provide software functions to automate EDC development and implementation, and serve a wide community of clinical trial organizations in a cost-effective fashion. The proposed development has two technology innovations: (1) Through implementation of advanced XML Form technologies and CDISC standards, eClinForce's eCRF engines will allow the XML-formatted eCRFs be designed through an user-friendly web interface, be generated automatically, and be processed system- independently. (2) With the eCRF engines built on XML technologies and CDISC standards, we can develop the automated EDC development application on the SaaS concept. The application will be developed specifically for and delivered over the Internet on an as-needed basis. Non-IT professionals will be able to use this web-based application to develop EDC systems without requiring programming efforts from software programmers. Clinical research organizations will be able to adopt this application by subscribing to the SaaS without licensing and owning it in-house. Phase I project will develop the eCRF engines, implement a proof-of-concept prototype of the SaaS application, and study its feasibilities. Phase II project will develop the SaaS application and test it in simulated trials.
Public Health Relevance: The proposed SaaS application will provide software functions to automate EDC development and implementation and serve a wide community of clinical trial organizations in a cost-effective fashion. The adoption of the application in clinical researches will dramatically reduce the cost and time consumed in EDC development and implementation, therefore deduce the total cost in drug development, and ultimately benefit the public.
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