Pre-Clinical and Clinical Data
Pre-clinical data are the important testing and safety data collected during research stage before the clinical trials begin. Tests like in-vitro tests, ex-vivo tests, biological evaluation, simulated use, engineering, performance tests, animal tests, computer modelling, lab tests, stability, shelf life etc. come under pre-clinical tests.
Clinical data are used to prove the to safety and performance of the device in question. The data can be obtained from the manufacturer through clinical trials or from scientific literature. Scientific literature can be about the actual device, equivalent devices or similar devices.
Pre-clinical tests also includes engineering, experimental data regarding design calculations, intended use, mechanical or electrical tests, reliability tests, evaluation of bio-compatibility and published literature applicable to the device or to similar device
Pre-Clinical data as name defines any experimental data before clinics, means safety and testing data collected from stage of research that begins before actual trials can begin in Humans.
Clinical Data is data from the experiments that are conduced in humans for various objectives like safety, efficacy etc.