KING OF PRUSSIA, Pa., Feb. 13 /PRNewswire/ -- Phoenix Data Systems (PDS) announced that it is expanding its eClinical Data Management services for Phase I-IV clinical trials at the Clinical Trials Congress in Orlando, Florida. The move comes as PDS is seeing increased demand for services to accompany its PDS Express(TM) electronic data capture (EDC) technology.
“We saw a significant upswing in demand for data management services in 2005,” said Dr. William Claypool, CEO of PDS. “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. 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.”
In recent years, increased use of EDC by sponsors has dramatically improved the efficiency of clinical trials while helping to shorten clinical development. However, many companies still struggle to manage eClinical implementations, integrate data and provide clean databases to regulatory agencies. PDS Data Management services are designed to address these issues by providing the sponsor with trained and experienced personnel who produce fully coded, fully queried data that is suitable for statistical analysis.
“Pairing these services with PDS technology is a powerful combination that helps sponsors, particularly emerging ones, to progress through the clinical development process,” Dr. Claypool said.
When a client requests data management services, PDS assigns a project manager with broad therapeutic experience to work closely with clinical trial team members to help define and implement the eClinical processes. PDS will provide a complete data management plan together with a fully tested and validated system in less than 30 business days. Included in the PDS offering are many additional activities that are traditionally outsourced in paper- based trials including:
- Project management - e-CRF preparation and initial edit checks creation - e-CRF completion guidelines - Data management plan generation - Non-logic consistency checks (Manual review and query generation) - Manual query resolution - Dictionaries, coding, and exception report approvals - Coding guidelines including: manual coding and review and approval of coding - Data correction plan - Final QC of study data
A PDS staff member will be available at the PDS booth #311 to answer questions about PDS full-service EDC offerings including eClinical Data Management services.
About Phoenix Data Systems
Founded in 1997, Phoenix Data Systems delivers cost-effective electronic data capture 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.
Phoenix Data Systems
CONTACT: Jim Dorsey, Phoenix Data Systems, +1-484-928-6048, orjdorsey@pdsedc.com; or Jonathan Morein, +1-215-957-0300 x217, or cell,+1-215-565-5377, or jmorein@dbcommunications.net, for Phoenix Data Systems
Web site: http://www.phoenixdatasystems.net/
