IVR System supports Phase I-IV clinical trials.
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Press Release Summary:
Specifically created as eClinical module, Interactive Voice Response System is tightly integrated with electronic data capture technology and is also functional in stand-alone implementations. System is accessed via telephone networks to deliver randomization for clinical trials and to gather patient-reported outcome data. By integrating ePRO data directly into EDC database, sponsors can corroborate findings of clinical studies with subject assessments.
Original Press Release:
Phoenix Data Systems Introduces Interactive Voice Response (IVR) Solutions
KING OF PRUSSIA, Pa., March 7 / -- Phoenix Data Systems (PDS) today launched PDS IVR, an Interactive Voice Response (IVR) system supporting Phase I-IV clinical trials. The system is the first IVR solution specifically created as an eClinical module that is tightly integrated with electronic data capture (EDC) technology. PDS IVR is also functional in stand-alone implementations.
PDS IVR enables trial sponsors to rapidly implement and effectively configure FDA-compliant trials. The system also helps to manage multi-site, multi-country clinical studies.
"IVR represents a valuable addition for our clients," said Dr. William Claypool, CEO of Phoenix Data Systems. "By incorporating these capabilities into our core EDC offering, PDS is making it easier to run clinical trials while further increasing efficiency, minimizing errors and reducing costs."
Interactive Voice Response (IVR) is a technology accessed via telephone networks to deliver randomization for clinical trials and to gather patient-reported outcome data. PDS IVR uses touch-tone keypad selection to interact with callers. It also provides appropriate responses, in many forms, including: voice, fax, callback or e-mail.
Gathering patient-reported data provides valuable subjective information regarding a participant's perception of his or her own well-being. When gathered electronically, this process is called ePRO (electronic patient reported outcomes). By integrating ePRO data directly into an EDC database, sponsors can easily corroborate the findings of clinical studies with subject assessments. Patient-entered data can be subjected to the same rigorous edit check processes as study-entered data. Sponsors are also assured that the reported data are stored in a secure, regulatory-compliant repository.
Unifying IVR and EDC technologies allows patient data to be transferred directly into EDC case report forms. It also simplifies data entry, reduces call times and supports more efficient data analysis. Since the data are integrated into the online EDC module, investigators can view subject assessments in a timely manner and monitors can review study data prior to site visits.
Additional benefits of the PDS IVR system include:
-- Reduced data entry for site personnel
-- Reduced query volume for data managers
-- Faster access to the IVR patient diary data for investigators
-- More accurate tracking of drug shipments and supplies
-- Improved clinical workflow and reduced time to database lock
-- Expanded accessibility of patient registration through any system interface
-- Centrally randomized patient information using IVR without re-entering eCRF data
-- Automatic updating of critical information for patients randomized in the IVR system in a central database
With the addition of IVR, PDS full-service EDC offerings encompass EDC, Web Reports, Data Management and integrated IVR to make running clinical trials easier and more efficient.
"Sponsors have demonstrated a clear preference to outsource clinical tasks rather than to acquire and manage these technologies in-house," said Dr. Claypool. "At the same time, they demand greater control and improved visibility over their clinical studies. Full-service EDC is the model that will provide the appropriate mix of technology and services to best help companies run successful trials on a consistent basis."
About Phoenix Data Systems
Founded in 1997, Phoenix Data Systems delivers cost-effective electronic data capture, interactive voice response, and data management services that give clinical data managers improved control to run well-managed studies. PDS solutions have been proven in more than 300 trials, including pivotal studies for eight new drug applications, without a single cost overrun. More information is available at http://www.phoenixdatasystems.net/.
CONTACT: Jim Dorsey of Phoenix Data Systems, +1-484-928-6048 or jdorsey@pdsedc.com;
