Monitoring of studies by EPL toxicologists is carried out using a time-proven system. A schedule of test site visits is prepared following the approval of the study protocol. For a short-term study, a schedule is arranged to observe critical phases of the study and to maximize the amount of data monitored. For long-term studies, the schedule is developed so that visits to the contract laboratory coincide with significant milestones in the study such as initiation of treatment, clinical pathology determinations and interim or final necropsies. Visits also are scheduled to correspond with routine study events such as test article administration, detailed clinical observations, ophthalmological examinations and histological preparation of tissues. In addition to inspection of laboratory operations, a systematic study data review is performed during each monitoring visit. Following each visit, a monitoring report is prepared detailing the study procedures and data that were reviewed and any significant deviations from the study protocol or laboratory SOPs that were noted during the audit. The monitoring report also includes discussion of the results of study evaluations completed by the date of the monitoring visit.
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