Infrastructure
TheraScan generates certified electronic copies of source documents which can stand in for paper originals when auditing and monitoring clinical trials. The system has three components required to copy, certify and upload source documents copies to the system.
ScanStation: This is the PC or thin client that will run the client-specific application used to scan, load and sign the source-document copies. The application is written to the TheraScan application programming interface (API) specification that controls communication between the ScanStation and Document Repository. The ScanStation requires a biometric smart-card reader and document scanner. Therapeias recommends a Precise Biometrics smart-card reader with “Match-On-Card” technology. For the scanner Therapeias can recommend models from both Canon and Fujitsu. One model in particular, the Canon DR-2580c, is well suited for use with the process. Biometric smart-cards are provisioned by Therapeias for each user who will certify copies using the system.
Document Repository: This is a combination database and web server that holds the scanned images generated by the ScanStation. These copies can subsequently be viewed over the network or Internet. The image files are kept within the database as binary objects for excellent scalability, security and ease of backup. Each client has a dedicated repository so that access can be restricted to specific users and/or locations. Post-certification document handling can be added per client specification. There are three implementation options for the Document Repository. Costs for each of these options are covered in the monthly maintenance agreement.
1. Hosted Option: Therapeias will host the repository on equipment in their data center. Each client will have a dedicated VMWare (virtual-machine) web server and Oracle database instance for their documents. Secure access to the repository will be set up according to client specifications. Database backups and system maintenance are be done by Therapeias.
2. Distributed Option: Therapeias will provide a stand-alone server to the client which can be sited behind the institutional firewall (as in the diagram). This system will have a minimum of 1TB of redundant disk space for the storage of documents, plus “best-in-class” availability options like redundant power supplies, multiple processors and ECC memory. The current system is the HP ProLiant ML350 G6 server. The standard setup will utilize a PostgreSQL database server with a client option to upgrade to an Oracle 11g database.
3. VMWare option: Therapeias will provide a virtual machine which can be subsequently run on a client-owned VMWare-compliant server. As with the distributed option the standard setup will have a PostgreSQL database with a client option to upgrade to an Oracle database.
Certification Server: This is the centralized system that certifies and confirms the validity of the copies submitted by the ScanStation or viewed by authorized users. User authentication is managed centrally by this server. Each Document Repository needs to have network access to the Certification Server which will be done via secure connection. The Certification Server is sited at our data center which adheres to TIA-942 standards. Only information required for certification is kept on the server, with no individually identifiable health information, eliminating HIPPA Privacy Rule concerns.