Itrica's products can be used stand-alone or in any combination depending on our client’s specific needs. All Itrica products have been engineered to be configurable and extensible to meet the unique demands of each clinical trial. Each product was architected to be easy for the end user to utilize while providing robust and sophisticated reporting and integration capability on the back end. Itrica has proven methodologies to ensure the successful integration of our products into client business environments that address the full range of customer lifecycle experiences.
·Clinical Trial Screener
·MARS Messaging Service
·Clinical Events Committee
·Serious Adverse Events Repository
Clinical Trial Screener
The Itrica Clinical Trial Screener is a web-based application that has been designed to allow investigative sites to screen subjects to determine subject eligibility and review reports. Its purpose is to aid in subject recruitment and provide sponsors and research teams with real time data on trial status. By using the Clinical Trial Screener, a trial sponsor should realize improved accuracy of reporting, improved compliance, more and better data from subjects and the elimination of cost and labor intensive manual processes.
CTS facilitates the electronic capture and integration of eligibility criteria across trials providing users with real time eligibility status and robust reporting features. CTS can be accessed through any industry standard browser or any of several handheld devices.
CTS has been designed to:
Empower trial sponsors and research teams with accurate and up-to-date entry criteria to determine subject eligibility status.
Provide for subject screening and recruitment for multiple trials simultaneously.
Deliver real time reports for trial sponsors, research teams and trial participants.
Be extremely flexible and easy for all trial participants to use.
The system is delivered in a SaaS model (Software as a Service) so that users do not need to install software or manage servers. Itrica manages the entire technology infrastructure, relieving its customers of all development and deployment issues.
MARS Messaging Service
The Itrica MARS Messaging Service (MMS) was designed as a patient retention system that automates and simplifies the communication between the investigate sites, the trial physicians and the trial subjects. MMS is built on Itrica’s technology infrastructure using two-way SMS messaging to facilitate interactions during a clinical trial. Increased communication with trial subjects improves the subject/doctor relationship, adherence to protocol requirements, awareness of trial milestones, and subject satisfaction throughout the trial, all of which result in improved subject retention. Increased communications also reduces the incidence of missed appointments and failure to take study medications, reducing the absolute number of events required to prove difference.
The Itrica MARS Messaging System:
Was designed by and for clinical trial specialists to facilitate easy and frequent communications with trial subjects.
Enables frequent trial subject status updates, digital data capture, and real time reporting features.
Engages the care givers into the communication process.
Empowers trial sponsors and research teams with accurate and up-to-date subject status information.
Empowers coordinators and trial physicians to respond more quickly to adverse events.
Delivers real time reports for trial sponsors, research teams and trial participants.
The Itrica MARS Messaging System was designed to be extremely flexible and easy for all trial participants to use. The system is delivered in a SaaS model (Software as a Service) so users do not need to install any software or manage servers. Itrica manages the entire technology infrastructure, relieving its customers of all development and deployment issues.
Clinical Events Committee
Itrica’s Clinical Events Committee (CEC) tool has been designed to automate the collection and communication of data required to review clinical events and reduce the effort required for all CEC participants to collect, review, share and adjudicate trial data while eliminating paper from the process. Our tool captures all data related to a CEC in digital form and puts it into a digital binder. Bulky paper binders filled with patient records, doctors' reports, ECGs, lab reports and other patient related data are replaced with electronic files that are viewed through a high performance document viewer on any industry standard web-browser.
The CEC application was built to provide many integration and extensibility points in order to maximize its ability to bring disparate data and document types into the digital binder, including data imported from many standard formats. To facilitate the digital reporting of the results of the CEC review, the integration services provide data export and import into many different systems including many eCRF systems.
Itrica’s visualization feature allows CEC members to review the entire digital binder for an event as a single file. The reviewer has the ability to zoom in or out, pan across the documents in the digital binder, rotate individual documents in the digital binder, and draw on and make custom annotations to any document. The documents are protected by a security component, and document encryption is built in and available.
The CEC web application is able to streamline the actual adjudication process. Itrica accomplishes this through the use of digital forms (including the adjudication form), electronic signatures, and team collaboration during the review process. Integral to the adjudication functionality is the workflow capability, which routes the documents to the appropriate party during and after the CEC process is complete. The output of the adjudication process aides your organization with the regulatory requirements by providing automated notification of the outcomes and digital archives of all CEC documentation.
Real-time data reporting offers easy to access, secure reports, which gives your team a window to the CEC process and allows you to track your adjudication compliance for risk analysis. All reports are extensible into many different formats, including Excel, Word, PDF, Images and HTML. Itrica offers custom reports for your specific business needs.
Serious Adverse Events Repository
Itrica’s Serious Adverse Events (SAE) Repository web application manages the flow of work in the SAE reporting process. The Itrica SAE Repository application was designed to eliminate the use of all paper documents in the SAE Reporting process. Itrica’s SAE application creates a digital view of all documents, facilitates and tracks queries, allows annotation and bookmarking, electronic signatures and document tracking. The Itrica SAE Repository tool provides the functionality to create, log, review, track, and manage communications between the site and the sponsor to assure timely reporting. Accurate status of all SAE communications is assured through automated logging and reporting.
The SAE Repository application supports Multiple Data Feeds including Email, Fax, Input, Output, Scanned, EDI, Web Services, and Uploads. The SAE application can automatically generate email notifications, daily and/or weekly reminders, alerts, and change notifications. The Integration Services assure system extensibility through the use of Web Services, XML, or Schemas to integrate with other operational systems.
The core feature of the SAE Repository solution is Itrica’s proprietary high resolution data visualization over low bandwidth connections, resulting in a very satisfying user experience. Itrica’s visualization feature allows SAE reviewers to review all documents that are associated with an event as a single file. Visualization enables viewing of multiple disparate documents, including text, handwritten notes, fax, medical records (i.e. ECG, MRI, Patient Records) and any other data relevant to the event.
The Itrica Portal was built from the ground up to support the unique functional and security requirements of the clinical trial process. The Itrica Portal provides single sign on capability to allow role-based access to all Itrica applications.
The Itrica Portal is also a sophisticated document management system; it is the entry point to provide for the secure sharing of trial documentation to parties who need access to critical trial data. The dynamic navigation feature makes the user experience easy and friendly, while providing robust role-based security for securing trial documents.