Integrating OpenClinica and TrialVista CTMS Data Using Comprehend Clinical
Transcription
Integrating OpenClinica and TrialVista CTMS Data Using Comprehend Clinical
Integrating OpenClinica and TrialVista CTMS Data Using Comprehend Clinical Agenda Introductions TrialVista Overview Comprehend Clinical Overview Why use Comprehend Clinical with OC? Comprehend Clinical Demonstration Questions www.comprehend.com Introductions Hunter Walker, CTO Atlantic Research Group [email protected] 13 years within Clinical Operations (CRO and biotech) Rick Morrison, Founder, CEO Comprehend [email protected] 10+ years developing clinical analytics software used by FDA and top pharma. www.comprehend.com TrialVista CTMS Overview TrialVista is a Clinical Trial Management System (CTMS) that allows clients to better control and manage their clinical development programs. •Built using Intuit’s Quickbase (SaaS) •No programming required •Modular Design •Easy to Use •Flexible API •Comprehensive Reporting •Automatic Email Notifications www.comprehend.com TrialVista Modules Investigator Database Regulatory Management IP Management Monitoring Visit Reports Project Management Patient Management Safety Surveillance Patient Reported Outcomes Budget and Finance (Inv Payments) Central Document Repository Study Q&A CRA Visit Calendar CRF Tracking (paper-based studies) Help Request Manager www.comprehend.com Problem There are a ton of different data collection systems now, even within a single study. EDC, CTMS, ePRO, Lab, Safety, and more! Study 1 Study 2 Study 3 www.comprehend.com Comprehend Overview Email & SMS Alerts Mobile Devices Standard Web Browser Intranet Portals www.comprehend.com Seamless actionable insights in real time www.comprehend.com Comprehend is not just BI, it substitutes or leverages: Data Warehouses Teams of Programmers ETL tools Collaboration suites BI tools Discrepancy Systems Custom Programs Clinical Trial Management Systems (CTMS) www.comprehend.com Features Ad-hoc reporting Role-based dashboards Intelligent click-through Filters and subsets Collaboration Reports www.comprehend.com Core Technology: LiveET™ Inference Mapping™ Data Metadata Config Automated schema-negotiation Pluggable domain-specific typing system www.comprehend.com Why Implement Comprehend Clinical with OpenClinica? Provides sponsors, CROs, and sites access to OC data via a view-only study portal Enables users to easily create OpenClinica Reports Compare visit data in OC with the Patient Schedule in TrialVista Show OC data entry status in relation to investigator payments www.comprehend.com Demonstration www.comprehend.com Future Comprehend Features www.comprehend.com Questions? www.comprehend.com