PHARMACEUTICALS

Study Monitoring and Submissions

Once a study is placed in a CRO, it is critical to monitor the progress of that studies to insure their compliance with GLPs, excellent science, accountability, and record keeping. Consultox, through the services of Dr. Parent and others, would schedule periodic visits to the individual laboratories where the studies are being carried out. Animal rooms would be visited, records and calculations checked, all aspects of GLP compliance reviewed, and QA/QC organizations and procedures monitored. Study progress, daily observations, dosing levels and effects, competence of technicians, environmental controls, food consumption, body weights, and cleanliness of the facilities would all be noted and reported to the sponsor. Once the studies are completed, it is critical that the report accurately reflect the findings of the study and that all aspects of the work have been reviewed internally and deviations noted. This monitoring effort is paramount to insuring that the study is accepted by whatever agency is receiving the data. Consultox will insure the issuance of a proper report and the conduct of an appropriate study or series of studies.