Introduction: Integrated summaries of safety are an integral part of the submission package for a new drug. These summaries comprise data of all patients from all clinical trials conducted during the course of the development process. Typically, data from about 1000-5000 patients from phase II to phase III studies are available. So-called clinical datapools have been established at Bayer in the late 1970's to accelerate the approval process and to support post marketing surveillance. The concept remarkably evolved over the last 20 years. Nowadays, efficacy analyses are also an important part of the services provided to improve the knowledge about a certain drug. These analyses are based on all company sponsored studies from phase II to phase IV. The presentation starts with a brief description of the concept of clinical datapools and of their maintenance over the whole life-cycle of a drug, including challenges as for instance introduction of new medical classification systems and changes of concepts such as switch from intercunrent diseases to adverse events. The second part of the presentation consists of a discussion of pros and cons of industry based meta-analyses in comparison to 'classical' literature based integrated reviews. The role of other sources for information as for instance spontaneous reports databases and large population based pharmaco-epidemiological databases is also addressed. Finally, examples for internal meta-analyses as well as for co-operations with external experts are given.