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BOSTON—Global biopharmaceutical services organization Parexel International Corp. has launched its Start-up and Accelerated Recruitment Team (START) program to help make patient recruitment and retention strategy, planning and execution more effective for clinical trial sponsors. The program is an expanded offering of services the company had already been providing clients, which now includes an expert recruitment team supported by new technology that it designed to substantially improve patient recruitment performance and achievement of last patient in (LPI) goals—at no extra cost compared to the old services.
"START relies upon a new suite of proprietary technologies and data assets to more accurately plan for recruitment milestones," says Joshua Schultz, Parexel's vice president of clinical operations for Clinical Research Services. "With these data, START is also able to implement pre-planned contingencies based upon ongoing information, helping to avoid potential problems."
"Successfully achieving LPI milestones requires using all of the levers that Parexel, as a global CRO, has at its fingertips," adds Dr. Mark A. Goldberg, the company's president of clinical research services and perceptive informatics. "Our expanded patient recruitment services let sponsors harness experience from some of the industry's strongest recruitment specialists and the power of a solid technology platform that streamlines the entire process."
Although START replaces the old service offering from the company, clients are not required to use the new program in its entirety, Schultz notes. For example, they can purchase patient recruitment services from Parexel—such as site selection, feasibility and study start-up—without purchasing other START services such as data management or monitoring. Also, the underlying technology and databases remain in-house as part of Parexel's assets and are not offered as standalone items for sale.
Four major proprietary technologies form the informatics heart of the new service. Three of them are tools: the Scenario Planning and Recruitment Calculator (SPARC), the Site Tracking and Readiness (STAR) tool and the Protocol and Enrollment Analysis Tool (PEAT).
"These technologies offer improved access to historical data at the site, country and trial level," Schultz says. "In addition, they allow for improved tracking, management and projection of startup and recruitment, allowing for increased proactive management and visibility for the clients."
The fourth technology at the core of START is the Investigator Intelligence Database, which works in conjunction with the SPARC to plan trials and identify high potential investigators. By comparison, Schultz says, investigator databases are often limited to lists of contact information, trial participation and therapeutic specialty.
The star of the new technology lineup seems to be SPARC, which the company contends is able to integrate data from across an organization to help a drug sponsor avoid costly delays caused by slow recruitment or poor patient retention.
As Schultz explains, SPARC pulls together data from three major sources for its planning and tracking capabilities. The first is trial-specific information from the client or Parexel's feasibility group, which includes the protocol, estimated country/site distribution, estimated enrollment rate and estimated enrollment period. SPARC then allows those estimates to be optimized based upon the other factors. A second source is site-level recruitment and startup data from Parexel's clinical trial management system and from the clinical research associates monitoring the sites. The third major source is country-specific historical information from Parexel.
"Clients are simply getting improved capabilities and a wider range of services offered instead of increased pricing," Schultz says. "We recognize that patient recruitment has become one of the core issues in our industry. The START group is part of a major strategic initiative at Parexel to offer a world-leading capability in the critical area of achieving LPI milestones."