TheraScan Overview
TheraScan is the next generation of Therapeias’ patented system for remote source-data verification using a web browser. The system utilizes a combination of document scanner and biometric smart card to create certified copies of paper documents which can stand in lieu of the originals per 21 CFR Part 11.
These copies are uploaded to the Document Repository and are then available for secure viewing over the network via a web browser. Thus, clinical trial monitors are now able to do offsite source-data verification without a site visit.
This provides significant savings on travel costs, greater control over the process with centralized management of the verification process and a secure backup of paper source documents.
New TheraScan features include:
• A RESTful web-service to allow users to integrate a custom client with their existing clinical trial systems (i.e. OpenClinica). The application programming interface (API) specification is available on request.
• A “multi-tier” architecture so document images can now be stored on a client-specific server behind the institutional firewall or hosted in the Therapeias data center. Certification records are still retained on centralized servers at the Therapeias data center.
• The ability to combine an XML data file with a related image file and thus certify both the image and the related data in a single operation. This improves the ability to organize and utilize the certified copies, including post-certification processing of the files.
• The option to certify additional file types like spreadsheets, sound files, word processing documents, video files or pdfs.
Implementation
TheraScan requires a minimum upfront investment to implement. Yet the returns are immediate. The only hardware required from our clients are the document scanners and biometric smart card readers for each ScanStation. The system can run on existing PCs or thin clients. Each user is issued a biometric smartcard which is provisioned by Therapeias for individual use. All other hardware, including the Document Repository server and Certification Server is provided by Therapeias as part of the contract.
No copies are kept on the local ScanStation so the loss, destruction or theft of the unit does not compromise the integrity of the study.
Because of the ease of implementation and support, ScanStations can be installed throughout the world. Minimal internet bandwidth is needed for the certification step, when making black and white copies, so even a dial-up connection is sufficient. As copies are retained on a centralized Document Repository, security and support needs at the individual sites are greatly diminished.
Access to the certified copies can be accomplished by any PC that is able to “see” the Document Repository over the network.
Finally, as source-data verification no longer requires a site visit, it can be done in near-real time. With immediate feedback site errors are quickly addressed and structural issues can be identified early and resolved before they become major headaches.