Phoenix expands clinical trial capabilities
response (IVR) system and a range of new services to accompany its
current electronic data capture (EDC) technology.
Phoenix's new IVR system is the first to be specifically created as an eClinical module and tightly integrated with electronic data capture (EDC) technology, said the firm.
The company has unified the two technologies to make running clinical trials easier and more efficient, allowing patient data to be transferred directly into the EDC case report forms and simplifying the data entry process.
"Sponsors have demonstrated a clear preference to outsource clinical tasks rather than to acquire and manage these technologies in-house and IVR represents a valuable addition for our clients," said CEO Dr William Claypool.
IVR is a technology accessed via telephone networks to deliver randomisation for clinical trials and to gather patient-reported outcome data.
Gathering patient-reported data provides valuable subjective information regarding a participant's perception of their own well-being. When gathered electronically, this process is called ePRO (electronic patient reported outcomes).
By integrating ePRO data directly into an EDC database, patient-entered data can be subjected to the same rigorous edit check processes as study-entered data.
IVR also helps trial sponsors to manage multi-site and multi-country clinical studies and provides added assurance that the reported data is stored in a secure, regulatory-compliant database.
Phoenix saw a significant upswing in demand for its data management services in 2005, as the increased use of EDC in recent years has dramatically improved the efficiency of the clinical trial process while helping to shorten drug development.
However, Phoenix also noticed that many companies were still struggling to adequately manage the eClinical software, integrate data and provide clean databases to regulatory agencies.
With this in mind, the company has also launched a new range of data management services designed to address these issues by providing the sponsor with trained and experienced personnel who produce data that is suitable for statistical analysis.
"We found that an array of support services beyond traditional EDC helped many companies to see how they could immediately improve their trials and reduce risk," said Claypool.
"Our ability to closely integrate our data management and our EDC offerings will enable us to provide our clients with the most efficient and cost effective method of data management," he said.
When a client requests data management services, Phoenix will now assign a project manager with broad therapeutic experience to work closely with clinical trial team members to help define and implement the eClinical processes.
Phoenix will provide a complete data management plan together with a fully tested and validated system and is also offering many additional activities that are traditionally outsourced in paper-based trials including project management, e-CRF preparation, e-CRF completion guidelines, data management plan generation, non-logic consistency checks, manual query resolution, and coding guidelines.
