InforMedix’s Med-eMonitor Enhancements Expand And Simplify Protocol Implementation Capabilities
InforMedix, Inc. today announced a major software upgrade that extends the functionality of its Med-eMonitor System™, a compliance-enhancing and monitoring platform that enables patients to report medication-compliance and bio-data to online databases via a hand-held electronic device. The enhancements enable clinical researchers to more rapidly and efficiently program Med-eMonitor to capture the patient-specific data needed for their large organized clinical drug trials. Such productivity gains during the critical deadline-driven clinical trial implementation phase will help spur the Electronic Patient-Reported Outcomes (ePRO) diary market, which is expected to grow to $3 billion by 2005, according to pharmaceutical industry experts.
Med-eMonitor’s enhanced functionality results from an exhaustive study in which InforMedix scientists and engineers identified the most common attributes from a large group of clinical protocols that would benefit from ePRO efficiencies. They then created a software system that enabled these attributes to be quickly and efficiently customized, via simple-to-use templates that researchers can access easily from a web-based browser. The templates allow administrators to quickly define user groups, enroll patients, manage schedule and study duration, set up questionnaires, deliver dosage instructions and define other key elements needed to prepare Med-eMonitor for use in a clinical study.
“The new improved software allows study administrators to deploy protocols in hours as opposed to the weeks typically found with other applications,” said Michael Gavin, vice president of research and development. “Administrators simply type into a secure web page details about medication, schedules and questionnaires in the clinical terms with which they are most familiar. Protocol formatting on the device is handled automatically. Without the need to develop custom software code, the system validation time is dramatically reduced. By streamlining the process and adding new features requested by our users, we’ve greatly extended Med-eMonitor’s capabilities, yet simplified the platform for our pharmaceutical and CRO (clinical research organization) partners.”
Gavin said that the Med-eMonitor’s backend software is now based upon industry and Internet standards using the Microsoft .NET framework. Unlike other ePRO solutions that use proprietary software that is functionally restrictive and expensive to maintain, and has to be specifically programmed for each protocol, the Med-eMonitor design is based on open standards. As a result, information gathered from clinical studies using the Med-eMonitor can be easily formatted and integrated with other applications to provide tailored solutions for clinical research.
Additionally, InforMedix has added a number of features that simplify both the operator and patient’s user experience, including:
- Full-size (100mm) Visual Analogue Scale (VAS) allows patients to quickly and easily enter numeric values (such as pain measurement or weight).
- A 6 digit Electronic Serial Number (ESN) combined with a 256-bit Global Unique Identifier (GUID) provides unprecedented safety and security for the system. The ESN also allows the clinical coordinator to easily and securely download patient-specific configuration files from the web site onto the Med-eMonitor device, reducing the time needed for the configuration process and simplifying patient deployment.
- Questionnaires can be triggered at various times related to medication ingestion in order to capture valuable dose-response information needed during a trial (e.g., in order to determine how quickly pain subsided once analgesic medication was taken, and the duration of action and degree of pain relief provided by the medication).
About InforMedix
Founded in 1997, InforMedix has developed the Med-eMonitor System to provide real-time medical management and patient communications for clinical drug trials. The Company has integrated a portable patient-interactive monitoring device, hardware, software and network communications system to enable pharmaceutical and biotechnology companies, and medical researchers to efficiently monitor and manage patients’ medication compliance, protocol adherence, clinical response, and safety. Med-eMonitor is specifically designed to improve patient medication compliance and protocol adherence in clinical drug trials. The Med-eMonitor System leverages InforMedix’s strong intellectual property consisting of 15 issued patents and 12 patents pending. The company’s patents have been cited as prior art by patent examiners in over 150 other issued patents.
Safe harbor provisions
This report contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. References made to the discussion of the risk factors are detailed in the Company’s filings with the Securities and Exchange Commission, including the report on Form 10-QSB for the quarter ended September 30, 2003, our Annual Report on Form 10-KSB for the year ended December 31, 2002, our prospectus dated April 8, 2003, as supplemented, our preliminary prospectus dated February 11, 2004 and our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Corporate Inquiries
Janet Campbell, COO, President
InforMedix, Inc.
(215) 796-1220 (Mob)
(301) 984-1566
janet.campbell@informedix.com
Healthcare Media
Greg McQuerter
McQUERTER, Inc.
(858) 450-0030
gmcquerter@mcquerter.com
Financial Media
Donald C. Weinberger
Andria Arena
Wolfe Axelrod Weinberger Assoc. LLC
(212) 370-4500
don@wolfeaxelrod.com
