RESTON, Va., Feb. 1 /PRNewswire-FirstCall/ -- PRA International , a leading global clinical research organization, today announced the achievement of several data management milestones and outlined plans for expanded electronic data capture capabilities.
The company processed 401 projects in 2005, encompassing approximately 103,000 patients and 1.5 million pages of data. The work resulted in 76 databases being locked, the majority for integration into future regulatory submissions. Additionally, using Clinical Data Interchange Standards Consortium (CDISC) methodology, another 77 database freezes occurred, many for ongoing data review by Data Safety Committees (DSCs). PRA maintains global data centers in Lenexa, Kan., Victoria, British Columbia and Swansea, Wales.
"PRA has the unmatched capability to collect, clean and integrate data from multiple sources and countries," said Greg Johnson, Vice President of Data Management. "Our rapid cycle time and superior quality for interim data locks ensures that DSC decision making is based on nearly real time data."
Johnson noted that in one recent interim DSC program, PRA's global data centers and clinical operations staff worked together to resolve over 30,000 queries in a six week period across 23 countries using the company's unique approach to locking data at the patient level.
Using its Dedicated Operations Center approach, the company also provides cross-functional teams of data managers, statisticians, programmers and clinical operations professionals to perform fully dedicated molecule lifecycle activities on specific client programs. Since 1999 when this approach was implemented, dedicated teams ranging from 19 to 130 professionals have been assigned to discrete client programs.
Later this quarter, the company will launch an enhanced electronic data capture (EDC) platform to enable PRA to provide EDC for all studies on a global basis. This EDC platform will also offer a hybrid EDC/paper solution to meet the investigative sites' business needs. Additionally, with this new platform, the company will continue to support any sponsors that wish to work with third-party EDC providers. To date, PRA has completed 49 EDC studies involving nearly 21,000 patients through a variety of technology platforms.
PRA will introduce an integrated web portal later this year that will further enhance efficiency and provide clients with real time data.
For more information about PRA's data management services, contact Greg Johnson at (250) 483-4400 or your PRA sales representative.
Cautionary Note Regarding Forward-Looking Statements
This news release contains forward-looking statements that are subject to risks and uncertainties relating to PRA International's future financial and business performance, as well as any other predictive statements dependent upon future events or conditions, or that include words such as "expect," "anticipate," "intend," "plan," "believe," "seek," "may," "will," "estimate" or similar expressions of futurity. You should not place undue reliance on any forward-looking statements, which represent the Company's statements only as of the date of this news release and are not intended to give any assurance as to actual future events. Factors that might cause future events to differ include: the success of the launch of our enhanced electronic data capture platform as well as the introduction of the integrated web portal and the value of those services to our clients; our ability to attract and retain qualified personnel; our ability to continue providing our services effectively, including the quality or accuracy of the data or reports provided and our ability to meet agreed upon schedules; the ability and willingness of our clients to continue to spend on research and development at rates comparable to or greater than historical levels; trends or events affecting the CRO industry and the demand for CRO services; government regulation, including regulatory standards applicable to CRO services; evolving industry standards; and technological changes. Events relating to PRA International could differ materially from those anticipated in these forward-looking statements and general business and economic conditions. Although these statements are based upon assumptions the Company believes to be reasonable based upon available information, they are subject to the foregoing risks and uncertainties as well as those described more fully in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our annual report on Form 10-K. This document can be accessed in the SEC's EDGAR database found at http://www.sec.gov . Please note that PRA International assumes no obligation to update any of the forward-looking statements in this release, except as required by applicable securities laws.
About PRA International
PRA International is one of the world's leading global clinical development organizations, with over 2,400 employees working from offices in North America, Europe, South America, Africa, Australia, and Asia. PRA, an ISO 9001:2000 registered company, delivers services to its clients through a unique approach called Project Assurance(R), which represents the Company's commitment to reliable service delivery, program-level therapeutic expertise, easy, global access to knowledge, and involved senior management.
To learn more about PRA International, please visit http://www.prainternational.com or call our World Headquarters at +1 (703) 464-6300.
PRA InternationalCONTACT: John Lewis, Director-Marketing and Public Relations of PRAInternational, +1-703-464-6338, lewisjohn@praintl.com
Web site: http://www.prainternational.com/
