EDC, Paper, Images

As the industry slowly moves toward site-based entry, companies are finding it necessary to support multiple modes of clinical data management, oftentimes within the same study. CPDM supports site-based entry with features such as role-based menus, electronic signatures, and site-based security.

Using software from Citrix®, CPDM is web-enabled and fully compatible with most browsers, minimizing the need to qualify hardware and software at the site. Data can be entered directly into a central database, meaning no intermediate data exists at the remote site.

Additionally, if some sites are unable or unwilling to participate in site-based entry, traditional paper-based data entry can still be utilized, eliminating the need for two separate CDM systems. CPDM can also be integrated with image management software, such as TeleForms®, to support fax-based and split-screen image-based data entry. Whatever your mode of entry, CPDM has a solution!

The ClinPlus Data Management system supports electronic data capture (EDC) via a CitrixXenApp^TM implementation. After a Citrix client browser plug-in is installed, investigator sites can access the system via any web browser.

Citrix XenApp^TM is a Windows^® application virtualization solution that centralizes application management in the datacenter and delivers applications on-demand to users anywhere using any device. Utilizing integrated application virtualization technology, XenApp overcomes the challenges associated with archaic application deployment methods to reduce the cost of application management by up to 50 percent, deliver applications instantly to users and secure application access.

A minimum of 1 server is required to host the Citrix presentation server, SAS and the ClinPlus Data Management system, and will support up to 25 concurrent, remote connections.  For larger implementations, 2+ servers accessed via a gateway server are required.  The SAS/Share server may also be a separated from the XenApp server(s).  Below is a link to Citrix XenApp product information.  You will need to contact a Citrix rep for  current pricing.

For more information about Citrix XenApp^TM please go to: http://www.citrix.com/English/ps2/products/product.asp?contentID=186

The current ClinPlus Data Management EDC Process provides the following functionality:

• Site Based Access-Allows administrators to restrict what information sites and investigators can view and edit within each study
• Role-Based Menus--Three key roles can be defined for users (SITE ENTRY, MONITOR and INVESTIGATOR) that tailor the system menu to each user's role
• System Security-Allows the administrator to restrict the access a user has to the different tasks and studies
• Data Structures with Role-Based Variables-Add variables to data structures to capture role based information such as monitoring status and investigator signatures
• Screen Design with Role-Based Fields-Allows administrators to control field access based on user's role
• Investigator Signatures-Allows an Investigator to attest to validity of data by applying an electronic signature
• Information-Allows access to system reports, URL links, etc