SharePoint and InfoPath for CTMS and EDC

Technology Background
Portals
The introduction of the Web Portal concept has been described as a major advance in internet technology comparable to the introduction of Active Server Pages। An important distinction between portals and traditional web sites is that portals allow the customization of content views and functionality based on specific users or groups providing a service orientated architecture easily adaptable to trial business process management.

The seminal “discovery” in spring 2003 for our group was that available portal technology provides a near perfect architectural framework for electronic management of the clinical trial paradigm. With tools like document management, workflow, flexible data grids, calendars, search and alerts, 90% of the functional requirements are built in. In combination with XML based web services portal software enables a common gateway for study management from inception to closure.

It is not the intention here to endorse any one vendor of portal or form technology but rather to make थे statement through example that new portal and form technologies should be strongly considered as options for developers and users of electronic clinical trial systems. Two of थे most popular commercial portal technologies are Plum Tree and IBM’s WebSphere.

Our group selected Microsoft Sharepoint Server as the portal platform for our CTMS. SharePoint Portal Server centralizes information from different systems by using the .NET Platform, Visual Studio.NET, ASP.NET, Common Language Run Time, Web Forms and Smart Pages, and a secure infrastructure. The contemporary .NET environment provided an application that fully leverages current investments, provides desktop synchronization, scales and is absorbent of future technologies ensuring a long lifecycle for the product.

Our principle of modifying existing software standards from commercial vendors as opposed to developing software from scratch allowed a small team of 2-3 to build a new platform capable of integrating multiple trials business process into one platform over a matter of months. We’ve eliminated disparate point solutions and dramatically reduced development costs. Basic technical support and future development of generic functionality will be done by the large vendor and their numerous “partners” freeing us to focus our expertise in development specific to clinical trials.

Forms
InfoPath is one of several new applications that enable the display and entry of data in a WYSIWYG forms based application without the need to write code. Other similar technologies are available from both Adobe and the W3C recommended standard for Web Forms, XForms. These new forms based applications are enabling the creation of XML data by the application instead of in a proprietary format. They also facilitate distribution of the forms over the web and entry of data both online and offline.

Emerging standards such as XSLT: XML Style Sheets, XPath query specifications, XSD: XML Schema, XML Digital Signatures, Namespaces, Webservices: SOAP, WSDL, UDDI make it possible to specify aspects of an application in XML rather than in code. The forms allow separation of the form’s logic from its presentation rendering forms device independent, because the data model can be used for all devices. With the data in XML format instead of a proprietary format it can easily integrate into multiple applications. InfoPath is able to integrate these standards with MS Office technology, allowing for synchronization with the desktop.

Portals (CTMS) + Forms (EDC)
InfoPath is used to create EDC tools for recording clinical data obtained from clinical trials of pharmaceuticals and devices. InfoPath forms are distributed and maintained on Sharepoint Server form libraries. SPS serves as the CTMS. When combined the two technologies provide a platform for rapid creation of full featured XML based electronic clinical trial management portals.

Technology Overview

An Enterprise Scale Integrated Research Platform.

Organizations that manage clinical trials who are also adopting enterprise portal technologies should be aware that through a strategy of adding minor modifications to off-the-shelf portal software and application of available XML-based WYSIWYG form technologies, our group has modeled an inexpensive but powerful Web-enabled clinical trial management system that leverages current investments, scales to enterprise level, and is absorbent of future technologies. Industry can now fully integrate clinical trial management solutions within the same portal platform used for enterprise business processes.

The Department of Veterans Affairs (VA) recognized new portal technologies out-of-the-box provide 90 percent of the functional requirements necessary for Web-enabled clinical trials management and has designed a portal-based system capable of study management from inception to closure. Unbound by legacy, VA took advantage of breakthroughs in software development environments, XML, and Web Services to provide standardization, interoperability, and 21 CFR 11 technical compliance while extending an enterprise platform to manage clinical trials. Because of the inherent modularity of portal software, the system ramps up to serve other business process needs of the organization, providing a common gateway to the whole of the enterprise making integration and presentation of disparate data sources a snap. The unique architecture also provides a price point within range of budget-constrained researchers and research organizations. Use of these technologies within VA has has been favorable. This author expects the application of portal technologies to the clinical trials paradigm to become de rigueur.

Bio-IT world post in 2004. You heard it here, first. -dave