Brentwood, TN -- February 8, 2005 -- Praxis, a company specializing in centralized patient recruitment and retention for clinical research studies, recently launched PraxisDirect, a program that allows sponsors and sites to track patient recruitment from patients’ initial responses through their randomization, utilizing one automated log. The program stores, tracks, and analyzes the data collected throughout a Praxis campaign in order to provide sponsors and sites with comprehensive information. Compared to other models, PraxisDirect provides sponsors with real-time analyses of patient recruitment and site performance data and permits sites to view an online referral log and site-comparison analysis. The program meets and exceeds HIPAA standards.

Enrollment metrics posted on PraxisDirect include: reasons why patients were disqualified from participating in the study at pre-screening as well as site screening visits; referral source; inquiry, pre-qualification, screening, and enrollment rate comparisons among recruitment tactics; sites’ average response time to Praxis referrals; the effect of site response time to referrals on enrollment; site-reported recruitment outcomes; total number of inquiries and respondents by site; weekly activity reports, and more.

“PraxisDirect empowers us to provide a higher level of service to our sponsors,” said David L. Fox, president and CEO of Praxis. “The technology allows us to focus on delivering results for our clients and presents the sponsor with a more convenient, real-time option for receiving enrollment metrics,” he added.

To ensure the security of patient data, PraxisDirect utilizes VeriSign® Secure Site Pro, a Cisco firewall, and serious physical security. Accessing PraxisDirect requires a unique username and password. The login information is used to determine which data a user is permitted to view and modify. Following HIPAA guidelines, sites may enter information that sponsors are not allowed to view or access.

Along with each referral’s pre-screening questionnaire, sites can access a log of all their Praxis referrals. They can complete information on the outcome of each referral and monitor the number of referrals they still need to contact. Sites may utilize the program’s manual entry function to record all potential subjects within PraxisDirect (not only the Praxis referrals). Sponsors benefit because they do not need to collect a separate screening/enrollment log--thereby eliminating double log-entry for sites. Private health information entered by sites is blinded to all users (including Praxis). For example, any medical information entered for subjects who have not signed an informed consent and data usage agreement (e.g. subjects screen-failed during an initial information call with study coordinators) will be part of the cumulative data analysis, but will never be associated with the individual.

“PraxisDirect makes it easier to keep up with referrals and increase enrollment,” noted Nancy Frey, study coordinator, Vanderbilt University Medical School, Asthma, Sinus & Allergy Program Research. “No one will slip through the cracks.”

Pharmaceutical company sponsors can log in to PraxisDirect to access real-time analysis of the recruitment results for their trial.

“Praxis is a pioneer in the patient recruitment industry in their offering of a comprehensive, online screening log so that sites no longer have to fax one in,” explained a study manager for a major pharmaceutical company. “Another advantage of the online comprehensive log is that the information can be accessed in real-time, rather than waiting each week to receive the faxed-in data for compilation and analysis.”

Praxis Communications, Inc., headquartered in Brentwood, TN, provides the pharmaceutical and biotech industries with a wide range of services for patient recruitment and retention for clinical trials including patient profiling, recruitment planning, centralized fulfillment, media relations, advertising, and program management. For more information, call Praxis at (615) 312-8207.

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