eShowcase
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
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.
Med-ic ECM
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
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
