Center Summary (click for larger image)

For the last 10 years, CRIS, Sierra's lead product, has responded to the industry's unmet triple-demand for data integration, compliance and convenient data accessibility by delivering solid information on clinical trials - from enrollment, protocol violations, and CRFs, to outstanding queries and center closeouts - in real time, anytime you need it, anyway you want to see it. Now in its seventh version, CRIS remains the original truly integrated, Part 11-compliant clinical research software package, which is why local, national and international medical products companies have chosen CRIS for numerous clinical research studies.

Overview of CRIS Clinical Trials Management Stores all study contact information; captures all necessary GCP documentation, including IRB approvals, lab certifications and customer-defined documents; creates links to electronic versions of all documents. Creates protocol and study center budgets; tracks actual expenses and compares between planned/actual costs. Maintains a central repository of all study communications and monitoring visit reports. "Laptop Mode" enables offline, disconnected use for on-site monitoring activities. Protocol Summary (click for larger image) Clinical Data Management Captures and tracks real-time and projected study enrollment for review over time. Enables CRF data input from virtually any mode (fax, paper, EDC, electronic import) with full audit trail to accommodate the study type and each site's capabilities. Safety Data Management Manages sponsor notification, reporting and review of serious adverse events with links to CRF data. Prints MedWatch and other mandated safety reports. Investigational Materials Tracking Tracks inventory and shipment of investigational materials by lot and serial number, including end-of-study reconciliation. Security, Configuration and Compatibility Detailed security matrix allows the sponsor to permit limited access by regional monitors, investigators, CROs and corporate partners. Comprehensive features include a "Protocol Configuration Wizard" and other tools for adapting studies to your workflow and terminology. One-click configurable to the unique protocol demands for drugs, devices, biologics, IVDs and combination products. Supports integration with standard email, word processing and spreadsheet tools. Compatible with your database configuration; works seamlessly with your existing applications. Click here to read how you can gain immediate ROI with CRIS. More for you from Sierra Beyond CRIS software tools and support, Sierra offers consulting via Sierra Medical Consulting (Sierra MRC). Scientists and medical experts guide start-ups and first time clinical trial sponsors, and support large corporations with stretched resources, in the planning, development, execution and analysis of their clinical trials. Contact us directly to hear more about how CRIS and Sierra MRC can reduce capital expenditures and other costs, and maximize your clinical research programs.