Abstract
Science and compliance are not competing forces. Only by simultaneous application of scientific principles and compliance requirements can appropriate, replicable safety evaluations be produced. Our organization has developed a system, identified as Telstar, by which teams that include members from each department are assigned to each study before its initiation and continue to be involved with the study until issue of the final report. This team is identified on the basis of appropriate expertise and experience and representation of appropriate areas. The Telstar team for each study includes the study director/report coordinator, the principal technician, the animal care technician, the data specialist, the information specialist, and the quality assurance auditor. Start and end times are assigned to each study period, including protocol approval, the various phases of study conduct and critical phase audits, specific raw data audits, beginning and ending of the in-life phase meetings, preparation of intermediate and final tables, review of tables, review of report results with senior staff, report writing by the study director, submission of report to senior staff, revision times, submission of report to quality assurance for audit, final review by study director after the quality assurance audit, final review by management (including review of the quality assurance audit results for the report), and report issue. Throughout the study, various team members interact with the study director, and scheduling is checked at twice-weekly management meetings, allowing study design and milestones to be modified if necessary. Use of this project team, with the study director coordinating specialists from each area, results in a quality product that meets all needs.