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Tools for Clinical Trials Professionals
Secure, Web-based product warehouses patient health data across multiple sites
Convergence CT (Honolulu, HI) offers an innovative software product that consolidates and manages patient health data for clinical trials and other health care environments. DB*FOCUS separates protected health information and de-identified patient data, encrypts it, and then provides clinical researchers access to the information through a secure, centralized, Web-based management system.
DB*FOCUS tracks all activity into and out of the patient record, either at a single location or across multiple sites. In this case, patient data are multi-encountered and longitudinally linked across all facilities in the clinical study. The security feature offered by the product enhances privacy compliance, including HIPAA.
According to Convergence CT, DB*FOCUS can save costs because its easy installation eliminates the need for a full-time database administrator, plus it also reduces organizational inefficiencies and optimizes resource utilization.
Convergence CT, (808) 536-3040, www.convergencect.com
Replace medication diaries and pill counts with this automatic compliance system
Information Mediary Corporation (Ottawa, Ont., Canada) has a unique device and software solution to one of the most persistent problems in clinical trials: noncompliance. Its Med-ic ECM (Electronic Compliance Monitor) can be used with any blister package to track medication use without active patient input.
The device uses sensor grid technology and a proprietary process of printed conductive inks to form a smart label that automatically tracks whether or not a patient takes medication. Med-ic ECM records the time each pill is expelled from the blister package, creating a record for analysis by clinical trial monitors.
The device's Med-ic ECM CertiScan RF Reader and CertiScan Compliance Monitoring Software capture and display patient compliance data with the latest RFID technology. The compliance monitoring system is disposable and features the technical controls to support 21 CFR Part 11 compliance without active input by the trial monitor.
Information Mediary Corporation, (613) 745-8400, www.med-ic.biz
Software delivers seamless supply chain management that integrates with third-party systems
ClinChain, Inc. (New Castle, DE) has found a way to help clinical supply professionals carry out all of their critical tasks with the click of a mouse. Version 3.2 of its ClinChain Plenish software package is a fully validated, 21 CFR Part 11-compliant software system that enables material receipts, manufacturing and primary and secondary packaging requests, site distributions, drug returns, and destructions.
ClinChain Plenish V. 3.2
At the heart of ClinChain Plenish are sophisticated data inheritance rules and inter-related drop-down menus that minimize user input and preserve data integrity. The software includes enterprise features such as multi-user client/server architecture, a robust reporting tool, broad genealogy tracking, and flexible data querying capabilities. It also integrates with other databases and third-party software standardized databases.
ClinChain, Inc., (302) 326-1342, www.clinchain.com