Planning ahead

New software technologies help Parexel team enhance clinical trial recruitment and execution

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BOSTON—Global biopharmaceutical services organizationParexel International Corp. has launched its Start-up and Accelerated RecruitmentTeam (START) program to help make patient recruitment and retention strategy,planning and execution more effective for clinical trial sponsors. The programis an expanded offering of services the company had already been providingclients, which now includes an expert recruitment team supported by newtechnology that it designed to substantially improve patient recruitmentperformance and achievement of last patient in (LPI) goals—at no extra costcompared to the old services.

"START relies upon a new suite of proprietary technologiesand data assets to more accurately plan for recruitment milestones," saysJoshua Schultz, Parexel's vice president of clinical operations for ClinicalResearch Services. "With these data, START is also able to implement pre-plannedcontingencies based upon ongoing information, helping to avoid potentialproblems."

"Successfully achieving LPI milestones requires using all ofthe levers that Parexel, as a global CRO, has at its fingertips," adds Dr. MarkA. Goldberg, the company's president of clinical research services andperceptive informatics. "Our expanded patient recruitment services let sponsorsharness experience from some of the industry's strongest recruitmentspecialists and the power of a solid technology platform that streamlines theentire process."

Although START replaces the old service offering from thecompany, clients are not required to use the new program in its entirety,Schultz notes. For example, they can purchase patient recruitment services fromParexel—such as site selection, feasibility and study start-up—withoutpurchasing other START services such as data management or monitoring. Also,the underlying technology and databases remain in-house as part of Parexel'sassets and are not offered as standalone items for sale.

Four major proprietary technologies form the informaticsheart of the new service. Three of them are tools: the Scenario Planning andRecruitment Calculator (SPARC), the Site Tracking and Readiness (STAR) tool andthe Protocol and Enrollment Analysis Tool (PEAT).

"These technologies offer improved access to historical dataat the site, country and trial level," Schultz says. "In addition, they allowfor 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 theInvestigator Intelligence Database, which works in conjunction with the SPARCto plan trials and identify high potential investigators. By comparison,Schultz says, investigator databases are often limited to lists of contactinformation, 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 anorganization to help a drug sponsor avoid costly delays caused by slowrecruitment or poor patient retention.

As Schultz explains, SPARC pulls together data from threemajor sources for its planning and tracking capabilities. The first is trial-specificinformation from the client or Parexel's feasibility group, which includes theprotocol, estimated country/site distribution, estimated enrollment rate andestimated enrollment period. SPARC then allows those estimates to be optimizedbased upon the other factors. A second source is site-level recruitment andstartup data from Parexel's clinical trial management system and from theclinical research associates monitoring the sites. The third major source iscountry-specific historical information from Parexel.

"Clients are simply getting improved capabilities and awider range of services offered instead of increased pricing," Schultz says."We recognize that patient recruitment has become one of the core issues in ourindustry. The START group is part of a major strategic initiative at Parexel tooffer a world-leading capability in the critical area of achieving LPImilestones."

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