The ISS Clinical Studies Solution provides a fully integrated and automated data/imaging solution for the pharmaceutical industry.

Industry and government standard audit trails track enterprise data collection, data management, and document image storage. Integrating industry standard products include Data Collection, Data Storage and Data Management, and Document Imaging Storage.

Data Collection
Cardiff's Teleform data collection system provides data capture through automated paper form scanning or electronic data capture using fax, modem, or Internet. A single customized form design can be used for all capture media. Data is edited and validated using Basicscript and results and audit trail information are stored in Oracle/SQL Server using standard Windows ODBC calls.

Data Storage and Data Management
Oracle's database is the standard. Data stored during the Teleform process becomes the basis for customized statistical reporting for government agencies. Audit trail data includes date, time, original image location, and original and final values corrected during Teleform verification.

Document Imaging Storage
Ricoh's E-Cabinet document imaging storage system provides enterprise image storage, access, and exchange. Innovative Systems & Solutions' Electronic Cabinet Import Utility (ECIU) automates the importation of images from Teleform into E-Cabinet.

Main Features

	Automated import of clinical data from CRF and paper forms
	Automatic import of document images with search keys
	Audit trails

Hardware/Operating System Supported

Microsoft Windows, NT, 2000