All parts of the trial are thoroughly reviewed prior the planning and conducting of the study. A wide range of experts in clinical practise and pharmacological research can be addressed for advise in the particular problem.
Statistical evaluation is based on analytical results and is performed using programs validated according to European Community regulatory authorities and FDA requirements.
The final report summarizes all details of the study, raw data and clinical activities. It contains thorough description of all stages of the study, data concerning the volunteers, medical records and experimental results and their statistical evaluation. In spite of a large volume of data, they are presented in a clearly arranged, preferably tabulated and graphic form.
Expert Reports in CTD format are usually submitted to regulation authorities as an integral part of the generic drug documentation. The Expert Report elaboration can be either a part of the bioequivalence study contract or can be worked up separately for any drug.