September 02, 2016
Non-clinical efficacy and safety testing during drug development is a complex, in many parts well-regulated process. One has to move under high time and budget pressure within the limits set by the authorities as well as strategic and economic needs. It is obvious that, before starting and during this complex process, all reasonable efforts have to be taken to have all required information and preparations in time in place.
Effective planning and execution of non-clinical projects require a clear view regarding the developmental phase the studies should support and a thorough appraisal of all available information about the test material and the findings of prior studies. Most of single studies are inter-connected, the initiation and/or interpretation of one study often depends on the results of other studies.
As a starting point, please find below a checklist of some general topics. You are of course welcome to contact us and discuss these topics and any other points in order to set up and offer you efficient and tailored services.